Lediga jobb Life Technologies Europe B.V. Nederlaenderna Fil i Stockholm

Job Description
We are seeking an experienced Field Service Engineer to join our BioProduction Service and Support team. In this role, you will travel to customer sites to install, service, update, and repair Thermo Fisher Single Use Technology (SUT) hardware and automation products.
This is a field-based role, primarily providing support to customers across the Nordics, UK and Ireland. In time, you will also support the full EMEA region. The role will require frequent travel on a weekly basis (75-100% of work time) to sites across EMEA. When not travelling, you will be able to work from home. We are ideally looking for a FSE based out in the Netherland.


What will you do?
• Support our customers by providing troubleshooting, installation, Preventative Maintenance (PM), repair services, verification and qualification services in a professional and timely manner
• Perform commissioning and qualification of equipment by implementing Site Acceptance Test (SAT) and Installation/Operational Qualification (IQ/OQ) Protocols
• Collaborate with internal partners to resolve customer issues and improve processes
• Provide basic product training and technical assistance on our instrumentation to our customers and internal Sales team
• Report all activities on Sales Force Service desk, providing customer feedback to management, hardware and software groups
• Aid in optimizing revenue and new product development opportunities; Assist in demonstration of our products to potential customers
• Maintain technical competency by attending trainings, employee meetings and remaining up to speed on new products, markets, customers and competitors
Who we are looking for:
• A degree in Mechanical, Electrical or Software Engineering (or similar), or equivalent work experience and knowledge
• Delta V or other control software experience preferred
• Some experience with Single Use Technology (upstream and/or downstream) preferred
• Commissioning and Qualifications (C&Q) experience in facility, equipment or utilities
• Knowledge of Corrective Action and Preventive Action (CAPA), change control, deviations management and document management systems
• Any experience with in the Field Service, Lab Maintenance or Calibration Engineering roles working with IVD instrumentation or medical devices of interest
• Comfortable working in a customer-facing role, with a customer centric approach
• Proficient in English (crucial); additional Nordic languages a plus
• A valid Driver’s Licence (required)
• Willing and able to travel extensively, sometimes at short notice (crucial)
• Self-sufficient; comfortable working independently; logical approach in setting work priorities Visa mindre

Job Title: Sr. Regulatory Affairs Specialist
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
Thermo Fisher is seeking an experienced Regulatory Affairs professional with IVD Regulation (EU) 2017/746 expertise, to join the exciting area of In Vitro Diagnostic and Clinical Research products as part of Thermo Fisher Scientific Life Sciences Solutions.
The position is located remotely in Europe, reporting to Manager of Regulatory Affairs, IVDR & EU Regulatory Intelligence, and will work in an international environment, cross-functionally, to guide the Company, including world-wide Legal Manufacturers and Manufacturing Operations, through their conversion to IVD Regulation (EU) 2017/746.
You will be part of the primary liaison group, at the forefront of the Company interactions with Competent authorities, in the region.
In addition, you will conduct global training for regulatory compliance, participate in process improvement projects, and assist with audits.
You will have the opportunity to interact with Thermo Fisher Scientific colleagues all over the world and have the ability to influence organization’s global policies and procedures to improve regulatory compliance.
You will continue to improve existing regulatory intelligence infrastructure that facilitates regulatory and business objectives by staying abreast of changes to relevant regulations and policies. Engage internal and cross-functional stakeholders by proactively outline and communicating risk and opportunities to regulatory strategies leading to internal policy development and alignment


What will you do?
Serve as a member of the EMEA Regulatory Affairs Shared Services department and will have direct line reporting to RA Manager and supporting Director of Regulatory Affairs/Clinical.
Function as a direct link between the Global and Local RA team members to ensure local and regional regulatory strategies are developed and aligned.
Act as subject matter expert regarding compliance to IVD Regulation (EU) 2017/746 and other EMEA IVD regulations.
Independently lead others and conduct regulatory assessments with minimal guidance or supervision
Influence all functions and levels in the organization to foster personal ownership of regulatory compliance.
Apply knowledge of device regulatory requirements in order to support sites in their successful conversion to IVDR compliance within defined regulatory timeframes.
Ensure continued compliance with ISO 13485 and global regulatory requirements from FDA, Health Canada, Therapeutic Goods Administration, Medicines and Healthcare products Regulatory Agency, and other applicable regions.
Participate in process improvement projects.
Supports process owners and global product manufacturing sites to address internal/external audit and inspection findings.
Responsible for SOP revisions/document creation/annual document review as assigned.
Review customer-facing communications as assigned.
Maintain current knowledge of international regulation, guidance and standards applicable to company products.


How will you get here?
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science without relevant direct experience.



Experience Requirements:
Must have a minimum of 5 years of IVD Regulatory Affairs experience, with expert knowledge of IVD Directive 98/79/EC and Regulation (EU) 2017/746.
Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
Direct and positive experience in communicating with Regulatory Authorities and internal partners.
Demonstrate in-depth understanding of technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Capacity to communicate regulations to all functions including technical, within the company



Required Qualifications:
High energy level; positive attitude; detailed oriented; works well under stress
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Ability to provide solutions based on knowledge of regulation and industry experience
Willingness to travel (~10-15%)
Comfortable with ambiguity and change
Comfortable working within colleagues in different regions under tight timelines
Excellent knowledge-based PC computer skills essential
Understanding of medical terminology


At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!
Send your applications through to sonia.zouave@thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Visa mindre

The job:
As our new Field Service Engineer, you will be supporting our Life Science Mass Spectrometry (LSMS) customers across the Nordics and will deliver all service activities, including installations, repairs, maintenance services, validation services, technical support etc. You will primarily support our Triple Quad and Orbitrap Mass Spectrometry instruments.


You will perform all service activities in line with internal rules and customer regulations and assure responsive telephone support and diagnostics as well as on-site services to exceed our customers’ expectations and support them in using Thermo Fisher Scientific instruments.
This is a field-based role, supporting customers across all of the Nordic countries, but with a particular focus Stockholm, Sweden. You will be on the road 4 to 5 days per week, with some longer trips international trips and overnight stays required (up to 20% per annum). We are looking for qualified candidates based in Denmark or southern Sweden.
Join us and start your career with a global organization which prioritizes career development, allowing you to achieve your best – both personally and professionally
Our Organisation


This role sits within our Instrument and Enterprise Services (IES) organization, which provides a single source for integrated lab service, support and supply management. Our customized service offerings and world-class service experts have the flexibility and experience to uniquely address our customer’s business needs. Whether they are looking to arrange for service on one instrument or are seeking resources to manage service and support for all their labs, there is an Integrated Services solution to meet their business needs.
What will you do?
Support our customers to use our Mass Spectrometry instruments by providing troubleshooting, installation, Preventative Maintenance (PM), repair services, verification and qualification services in a professional and timely manner
Perform all Service Activities in line with internal rules and customer regulations
Provide responsive telephone and diagnostic support to our customers, as well as on-site services; actively promote our contract products
Achieve customer loyalty and escalate issues if necessary to solve critical tasks in the fastest way possible
Manage the company’s assets provided, such as Stock/Inventory of Parts, Computer, Telephone, general Tools, Software, Company Car, Manuals etc.
Co-ordinate with a variety of internal partners for service planning/scheduling (Dispatching, Team Leader etc.)
Provide accurate and timely reporting of all activities (e.g. Field Service Reports, Expense Reports, etc.)
Liaise with Sales team regarding lead generation, customer activity and updates

Who we are looking for:
A Degree in Engineering or a Life Science; or equivalent work experience & knowledge
Hands-on experience of mass spectrometry instrumentation (essential)
Professional experience in servicing analytical instruments (gained either as an Engineer or when working as a Scientist or Technician in a lab) (essential)
Fluent in English (essential); additional Nordic languages a plus
A valid Driver’s Licence (essential)
Comfortable working in a customer-facing role, with a customer-focussed mindset
Strong organizational and administrative skills
Self-sufficient; comfortable working independently with minimal oversight; logical mindset in setting work priorities
Willing and able to travel extensively on a weekly basis across the region (4 to 5 days per week), including some overnight stays and longer trips (up to 20% per annum)

What’s in it for you:
Excellent career progression opportunities with a large and growing global employer
Competitive salary, plus performance bonus & full benefits package
Company car

We look forward to receiving your application in English. If you have any questions about the role, you can contact the Recruiter, Daria Skucha at: daria.skucha@thermofisher.com
About us:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.
Apply today!
http://jobs.thermofisher.com Visa mindre

Job Description
Thermo Fisher Scientific is currently recruiting for an inside sales Technical Sales Specialist, Flow Cytometry and Antibodies to grow the Flow Cytometry reagent and Antibody consumables portfolio. The successful candidate will have the ability to build relationships with Key Opinion Leaders and life science customers, position and sell relevant products across customer applications.
The position sells the Flow Cytometry reagent and Antibody consumables product portfolio in an assigned geography in accordance with approved sales and marketing plans. The Technical Sales Specialist will comprehend and utilize product features, benefits and applications accompanied with selling and business building skills to successfully promote and consummate the sale of Company products and services to achieve or exceed the assigned territory sales plan.
The Technical Sales Specialist will also be the primary driver of business development at assigned major customer call points to penetrate and grow current and new business. The Sales Specialist will be recognized as a technical leader within the sales force that drives strategic objectives and adoption of innovative products.
Major Responsibilities
This individual’s responsibilities will include, but may not be limited to the following specific responsibilities:
Drive sales activities to close opportunities to meet or exceed revenue goals, profit goals, and market share goals consistently within expense guidelines.
Demonstrate clear product/technology expertise to confidently serve as the field-based expert in Immunoassays.
Visit all customer levels and functional areas, using solution selling techniques within assigned territory to influence purchasing decisions.
Engage with our distribution channel partners to train on the portfolio, generate leads and close opportunities.
Demonstrate use of advanced selling skills in the field, such as making good opening statements, connecting with the customer, asking high gain questions, creating the value proposition and closing. Has proven solution and large opportunity selling skills.
Develop presentations and customer proposals including structuring appropriate pricing and contract milestones.
Prospect for new opportunities to successfully develop leads and sell assigned portfolio of products and services.
Set-up and coordinate technical product presentations by and / or with internal customers such as Research & Development, Marketing, other Sales Specialists and / or Field Application Scientists either on customer site or locally.


Essential Skills
Communicates effectively, and is the ‘connector’ within the large matrix between customer, field application specialists, commercial sales team, product management, different sales teams, support, service, marketing, executive, and other salient groups to develop business.
Maintain and increase current customer database through company customer relations management software.
Office based; with 25% time for travelling to customers
Utilize proven organizational skills to successfully manage territory sales activities.
Provide comprehensive information on all activities to Direct Manager, Sales Representatives and District Managers in supported territories.
Participate consistently and play an active positive role on regional calls and other operating mechanisms.
Provide regularly oral and written communication of successes, failures, best practices etc to improve the overall operating efficiency of the team, region and sales organization.
Contact and return calls to research scientists and management contacts at all accounts for sales presentations, information through telephone, e-mail or personal visits daily.


Experience & Technical Requirements:
Requires a minimum Master’s Degree in Cell Biology, Immunology, Biology, Molecular Biology, Biochemistry, Chemistry or related field; or the equivalent knowledge and industry/functional experience.
Excellent technical skills and experience in the Flow Cytometry workflow and Antibodies knowledge required.
Previous sales experience preferred
Ability to navigate accounts in broad geography effectively and advance the capital equipment sales process consistently.
Highly proficient sales and organizational skills, ability to manage multiple high value, long sales cycle business opportunities simultaneously.
High motivation and energy level to develop new business



Applications will be received via email. Please send across a CV and Cover letter to Sonia Zouave, who is recruiting for this position. Visa mindre

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com
Do you want to be part of our journey into the future? As a company we are impassioned to make a difference within the Life Science segment. We are searching for candidates with the same passion to join our team.
This role is a great role for a Life Sciences graduate with some sales experience who is ready to kick start their career.
We offer an outstanding opportunity to work with some of the most exciting products within biotechnology. Our organization is developing, and we guarantee an engaging and results-oriented position, in an international environment. This position will promote the development of the successful candidate, with training provided to give insight into our broad product portfolio and improve your selling skills.
The role's primary functional objective is direct contact with customers, to initiate and develop relationships, which will ultimately generate sales. As an Inside Sales Rep, you will be using the telephone and web conferencing software as your primary tools of communication.
The position is permanent and will be based in our Stockholm office with a dynamic and fast paced team.
Key responsibilities:
Identify sales opportunities with new and existing customers and successfully handle the sales of Company products and services to achieve or exceed the assigned territory sales plan
Coordinate sales processes for assigned accounts for an assigned geography in accordance with approved sales and marketing plans
Participate in sales, product and systems training, marketing campaigns, special projects as presented by the Company to develop appropriate selling skills consistent with Company philosophy, policies, and procedures
Maintain and increase current customer database through Company customer relation’s management software (Sales Force CRM)
Regularly provide written and verbal communication of successes, failures, standard methodologies, to improve the overall operating efficiency of the team, region and sales organization
Connect with research scientists at all accounts for product information and sales presentations
Coordinate quotations within Company Guidelines by extending competitive pricing as needed to maintain and increase revenues with guidance from Management and/or Marketing
Support marketing programs and programs in other territories as assigned by the Sales Manager
Run and close sales leads generated by colleagues in Marketing and Technical Support



Experience/Qualifications/Qualities:
Minimum BSc within Life Sciences strongly preferred
Some experience from a sales function in relevant industry would be beneficial
Excellent written and verbal communication skills
Strong capabilities to interact optimally with all customer types
Ability to function effectively in a high performance team
Ability to manage time optimally to prioritize and complete tasks required
Demonstrate a positive demeanor and desire to succeed
Exhibits a high degree of flexibility in adapting to a constantly evolving business environment
Digital literacy in MS Word, Excel, Outlook, PowerPoint, or similar programs required



We look forward to receiving your application, including a cover letter and CV in English.
Application deadline: 28th March 2022
In case of any questions, feel free to reach out to: Daria.Skucha@thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status Visa mindre

CUSTOMER CARE REPRESENTATIVE
Stockholm
Thermo Fisher Scientific är ett globalt läkemedel- och bioteknikbolag med 75 000 anställda och en årlig omsättning på över 25 miljarder dollar.
I Sverige är vi cirka 1,000 Thermo Fisher Scientific-anställda som jobbar ifrån fyra kontor och hemmakontor. Vi har flera olika verksamheter, men vi delar alla samma mål - att kunna hjälpa våra kunder göra världen hälsosammare, renare och säkrare.
På Kungsholmen i centrala Stockholm har vi ett kontor som förser våra kunder med förbrukningsprodukter, instrument och programvaror inom life-science. Vi utökar nu vårt team på 11 personer inom Customer Care med ytterligare en dansk- eller norsktalande. Du kommer att bidra till att bygga goda relationer till våra kunder, representera företaget samt bidra till en bra kundupplevelse.
Om jobbet
Du kommer att stötta vår nordiska organisation med kundservice, främst via email, men även via telefon
Dina ansvarsområden:
Behandla beställningar
Uppföljning och support av beställningar och fakturor
Stötta kunder som gör order via företagets webbutik
Besvara kundklagomål för att säkerställa ett bra kundnöjdhetsresultat
Samarbeta med nordiska och globala kollegor samt externa kontakter för att lösa problem samt återkoppla information till kunderna
Support till våra säljare
Arbeta med förbättringsprojekt



Vem söker vi?
Vi söker dig som har ett brinnande intresse för kundservice samt tidigare erfarenhet från liknande roll inom kundservice och/eller serviceyrke.
Som person är du engagerad, driven och serviceinriktad person. Du har god förmåga att arbeta självständigt och trivs med en arbetsmiljö med högt tempo. Du klarar att både prioritera och hantera kunder, även i utmanande situationer.
Du trivs med en ansvarstagande roll där du även kan driva utveckling av processer, utbildning och andra förbättringsprojekt.
Du är flytande i tal och skrift i danska eller norska samt svenska och engelska.



Är du intresserad?
Letar du efter ett meningsfullt jobb på ett internationellt företag som har starka värderingar? Vill du ha ett jobb med eget ansvar där du verkligen kan göra en skillnad i människors vardag? Om detta låter intressant så kan du vara den personen vi söker!
SÖK NU via vår karriärsida https://jobs.thermofisher.com/
Har du frågor kontaktar du: Sonia Zouave, Recruiter Nordics, sonia.zouave@thermofisher.com
Välkommen med din ansökan snarast med sista ansökningsdatumet 2022, 31 Januari
Urval sker löpande, så skicka in din ansökan så snart som möjligt! Visa mindre

Job Title: Sr. Regulatory Affairs Specialist
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
Thermo Fisher is seeking an experienced Regulatory Affairs professional with IVD Regulation (EU) 2017/746 expertise, to join the exciting area of In Vitro Diagnostic and Clinical Research products as part of Thermo Fisher Scientific Life Sciences Solutions.
The position is located remotely in Europe, reporting to Manager of Regulatory Affairs, IVDR & EU Regulatory Intelligence, and will work in an international environment, cross-functionally, to guide the Company, including world-wide Legal Manufacturers and Manufacturing Operations, through their conversion to IVD Regulation (EU) 2017/746.
You will be part of the primary liaison group, at the forefront of the Company interactions with Competent authorities, in the region.
In addition, you will conduct global training for regulatory compliance, participate in process improvement projects, and assist with audits.
You will have the opportunity to interact with Thermo Fisher Scientific colleagues all over the world and have the ability to influence organization’s global policies and procedures to improve regulatory compliance.
You will continue to improve existing regulatory intelligence infrastructure that facilitates regulatory and business objectives by staying abreast of changes to relevant regulations and policies. Engage internal and cross-functional stakeholders by proactively outline and communicating risk and opportunities to regulatory strategies leading to internal policy development and alignment


What will you do?
Serve as a member of the EMEA Regulatory Affairs Shared Services department and will have direct line reporting to RA Manager and supporting Director of Regulatory Affairs/Clinical.
Function as a direct link between the Global and Local RA team members to ensure local and regional regulatory strategies are developed and aligned.
Act as subject matter expert regarding compliance to IVD Regulation (EU) 2017/746 and other EMEA IVD regulations.
Independently lead others and conduct regulatory assessments with minimal guidance or supervision
Influence all functions and levels in the organization to foster personal ownership of regulatory compliance.
Apply knowledge of device regulatory requirements in order to support sites in their successful conversion to IVDR compliance within defined regulatory timeframes.
Ensure continued compliance with ISO 13485 and global regulatory requirements from FDA, Health Canada, Therapeutic Goods Administration, Medicines and Healthcare products Regulatory Agency, and other applicable regions.
Participate in process improvement projects.
Supports process owners and global product manufacturing sites to address internal/external audit and inspection findings.
Responsible for SOP revisions/document creation/annual document review as assigned.
Review customer-facing communications as assigned.
Maintain current knowledge of international regulation, guidance and standards applicable to company products.


How will you get here?
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science without relevant direct experience.



Experience Requirements:
Must have a minimum of 5 years of IVD Regulatory Affairs experience, with expert knowledge of IVD Directive 98/79/EC and Regulation (EU) 2017/746.
Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
Direct and positive experience in communicating with Regulatory Authorities and internal partners.
Demonstrate in-depth understanding of technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Capacity to communicate regulations to all functions including technical, within the company



Required Qualifications:
High energy level; positive attitude; detailed oriented; works well under stress
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Ability to provide solutions based on knowledge of regulation and industry experience
Willingness to travel (~10-15%)
Comfortable with ambiguity and change
Comfortable working within colleagues in different regions under tight timelines
Excellent knowledge-based PC computer skills essential
Understanding of medical terminology


At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!
Send your applications through to sonia.zouave@thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Visa mindre

Job Title: Sr. Regulatory Affairs Specialist
Location/Division Specific Information
Sweden
How will you have an impact?
Thermo Fisher is seeking an experienced Regulatory Affairs professional with IVD Regulation (EU) 2017/746 expertise, to join the exciting area of In Vitro Diagnostic and Clinical Research products as part of Thermo Fisher Scientific Life Sciences Solutions.
You will be part of the primary liaison group, at the forefront of the Company interactions with Competent authorities, in the region.
In addition, you will conduct global training for regulatory compliance, participate in process improvement projects, and assist with audits.
You will have the opportunity to interact with Thermo Fisher Scientific colleagues all over the world and have the ability to influence organization’s global policies and procedures to improve regulatory compliance.
You will continue to improve existing regulatory intelligence infrastructure that facilitates regulatory and business objectives by staying abreast of changes to relevant regulations and policies. Engage internal and cross-functional stakeholders by proactively outline and communicating risk and opportunities to regulatory strategies leading to internal policy development and alignment


What will you do?
Serve as a member of the EMEA Regulatory Affairs Shared Services department and will have direct line reporting to RA Manager and supporting Director of Regulatory Affairs/Clinical.
Function as a direct link between the Global and Local RA team members to ensure local and regional regulatory strategies are developed and aligned.
Act as subject matter expert regarding compliance to IVD Regulation (EU) 2017/746 and other EMEA IVD regulations.
Independently lead others and conduct regulatory assessments with minimal guidance or supervision
Influence all functions and levels in the organization to foster personal ownership of regulatory compliance.
Apply knowledge of device regulatory requirements in order to support sites in their successful conversion to IVDR compliance within defined regulatory timeframes.
Ensure continued compliance with ISO 13485 and global regulatory requirements from FDA, Health Canada, Therapeutic Goods Administration, Medicines and Healthcare products Regulatory Agency, and other applicable regions.
Participate in process improvement projects.
Supports process owners and global product manufacturing sites to address internal/external audit and inspection findings.
Responsible for SOP revisions/document creation/annual document review as assigned.
Review customer-facing communications as assigned.
Maintain current knowledge of international regulation, guidance and standards applicable to company products.


How will you get here?
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science without relevant direct experience.



Experience Requirements:
· Must have a minimum of 5 years of IVD Regulatory Affairs experience, with expert knowledge of IVD Directive 98/79/EC and Regulation (EU) 2017/746.
· Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
· Direct and positive experience in communicating with Regulatory Authorities and internal partners.
· Demonstrate in-depth understanding of technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
· Capacity to communicate regulations to all functions including technical, within the company


Required Qualifications:


High energy level; positive attitude; detailed oriented; works well under stress
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Ability to provide solutions based on knowledge of regulation and industry experience
Willingness to travel (~10-15%)
Comfortable with ambiguity and change
Comfortable working within colleagues in different regions under tight timelines
Excellent knowledge-based PC computer skills essential
Understanding of medical terminology


Please note, there is a preferred candidate for this role.

http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Visa mindre

Project Manager – Service Excellence
Location:
Europe with regular travel to our sites in Uppsala, Sweden and Freiburg, Germany


Immunodiagnostics Division


Thermo Fisher Scientific’s ImmunoDiagnostics Division (IDD) develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and follow-up of allergy and autoimmune diseases. With 1,900 employees worldwide, IDD is the global leader in in vitro IgE testing for allergy and the European leader in autoimmunity diagnostics.


How will you make a difference?


As a key member of the Global Services Management Team, you will be responsible for the project management of key services programs and initiatives, planning, organizing, and steering projects towards goals and objectives. The project manager in Global Services will play an integral part of the corporate mission to make the world cleaner, healthier and safer.


What will you do?


You will join six other colleagues in the Global Service Management Team and report into IDD’s Sr Director, Global Services. Project management responsibilities include the coordination and completion of projects on time, within budget and scope. Overseeing all aspects of multidisciplinary projects, creating project charters, coordinating and leading core project teams, setting deadlines, assigning responsibilities and monitoring and summarizing progress of projects within Global Services, Service and other departments and functions to ensure project deliverables are achieved on time and within budget. The Project Manager will be the Global Services, Process Manager for Thermo Fisher Scientific's - Practical Process Improvement (PPI) business system.


How will you get there?


To succeed in this role you should have previous Project Management experience ideally from a similar industry and be someone who enjoys working cross-functionally in an international environment and matrix organisation.
We are looking for someone with the following experience and skills:


• A Bachelor’s or MSc degree. Ideally in life science, biochemistry, biotechnology or similar related field
• Minimum of three years project management experience
• Project Management Professional (PMP) / PRINCE II / PMI certification is a plus
• Fluent English spoken and written is required, speaking additional language/s is desirable.
• Must be willing to travel up to approximately 20% of time in Europe
• Customer centric – Customer First attitude
• Strong alignment with Thermo Fisher 4i values of Integrity, Innovation, Involvement and Intensity


What we can offer:


• A career in an international company with a global impact
• Development through continuous learning and developing skills and abilities
• Cooperation with colleagues and teams across business functions, divisions and countries
• Interaction and exposure presenting to senior leaders and executives
• Opportunity to manage high visibility high impact strategic projects


APPLY NOW on our career site: http://jobs.thermofisher.com


We will review applications on an ongoing basis so please apply as soon as possible but latest 8th July 2021


If you have questions about Thermo Fisher Scientific and/or the position - please contact Victoria Johansson (Senior Recruiter Nordics) – Victoria.johansson@thermofisher.com
Apply Now










We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
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Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status. Visa mindre

I Sverige är vi cirka 1,000 Thermo Fisher Scientific anställda som jobbar ifrån fyra kontor och hemmakontor. Vi har flera olika verksamheter, men vi delar alla samma mål - att kunna hjälpa våra kunder göra världen hälsosammare, renare och säkrare.
På Kungsholmen i centrala Stockholm har vi ett kontor som förser våra kunder med instrument, programvaror och förbrukningsprodukter inom Life-science. Vi utökar nu vårt team på 11 personer inom Customer Care och erbjuder en fast anställning. Du har en viktig roll när vi utökar med nya produkter och utökad försäljning. Du kommer att bidra till att bygga goda relationer till våra kunder, representera företaget samt bidra till en bra kundupplevelse.
Om jobbet
Du kommer att jobba med offerter och anbud för instrument på vår nordiska marknad. Det innebär att du arbetar med att utforma anbud där du på bästa sätt bemöter de förfrågningar som kommer in. Du följer anbudets process från start till mål. Det innebär att supportera säljare med att administrera och svara på anbud, skapa offerter, lägga beställningar, fakturera, koordinera leveranser, hanterar och skeppa demoinstrument etc.
Arbetet ställer krav på att självständigt söka information, granska och författa anbud, granska kontrakt och avtal samt vara detaljfokuserad. Detta i ett nära samarbete med säljare samt övriga kontakter internt och externt.
Vem söker vi?
Vi söker dig som har tidigare erfarenhet av att jobba med anbud, upphandling och orderhantering, gärna från verksamhet inom sjukhus och landsting. Vi ser även inköp inom detta område som en meriterande erfarenhet.
Som person är du administrativt lagd och har ett systematiskt sätt att arbeta, du har ett öga för detaljer samt är inte rädd att påvisa avvikelser. Du är uthållig och har ett driv av att utreda frågor och genomföra projekt.
Du är flytande i tal och skrift i svenska, engelska samt meriterande om du även kan norska, danska eller finska.
Troligen har du en högskoleutbildning eller motsvarande erfarenhet. Vilket har gett dig en god kommunikationsförmåga samt förmåga att författa avtal- och anbudstexter.
Är du intresserad?
Letar du efter ett meningsfullt jobb på ett internationellt företag som har starka värderingar? Vill du ha ett varierande jobb med eget ansvar där du verkligen kan göra en skillnad i människors vardag? Om detta låter intressant så kan du vara den personen vi söker!
SÖK NU via vår karriärsida https://jobs.thermofisher.com/
Har du frågor kontaktar du: Madelene Holm, Recruiter Nordics, madelene.holm@thermofisher.com
Välkommen med din ansökan snarast med sista ansökningsdatumet 2021-03-14.
Urval sker löpande, så skicka in din ansökan så snart som möjligt! Visa mindre

I Sverige är vi cirka 1,000 Thermo Fisher Scientific anställda som jobbar ifrån fyra kontor och hemmakontor. Vi har flera olika verksamheter, men vi delar alla samma mål - att kunna hjälpa våra kunder göra världen hälsosammare, renare och säkrare.
På Kungsholmen i centrala Stockholm har vi ett kontor som förser våra kunder med instrument, programvaror och förbrukningsprodukter inom life-science. Vi utökar nu vårt team på 11 personer inom Customer Care och erbjuder en visstidsanställning t.o.m. januari 2022. Du har en viktig roll när vi utökar med nya produkter och utökad försäljning. Du kommer att bidra till att bygga goda relationer till våra kunder, representera företaget samt bidra till en bra kundupplevelse.
Om jobbet
Du kommer att stötta vår nordiska organisation med kundservice, främst via email, men även via telefon.
Dina ansvarsområden:
Behandla beställningar
Uppföljning och support av beställningar och fakturor
Stötta kunder som gör order via företagets webbutik
Besvara kundklagomål för att säkerställa ett bra kundnöjdhetsresultat
Samarbeta med nordiska och globala kollegor samt externa kontakter för att lösa problem samt återkoppla information till kunderna
Support till våra säljare
Arbeta med förbättringsprojekt

Vem söker vi?
Vi söker dig som har ett brinnande intresse för kundservice samt tidigare erfarenhet från liknande roll inom kundservice och/eller serviceyrke.
Som person är du engagerad, driven och serviceinriktad person. Du har god förmåga att arbeta självständigt och trivs med en arbetsmiljö med högt tempo. Du har en förmåga att både prioritera och hantera kunder, även i utmanade situationer.


Du trivs med en ansvarstagande roll där du även kan driva utveckling av processer, utbildning och andra förbättringsprojekt.
Du är flytande i tal och skrift i norska och/eller danska samt svenska och engelska.


Är du intresserad?
Letar du efter ett meningsfullt jobb på ett internationellt företag som har starka värderingar? Vill du ha ett jobb med eget ansvar där du verkligen kan göra en skillnad i människors vardag? Om detta låter intressant så kan du vara den personen vi söker!


SÖK NU via vår karriärsida https://jobs.thermofisher.com/
Har du frågor kontaktar du: Madelene Holm, Recruiter Nordics, madelene.holm@thermofisher.com


Välkommen med din ansökan snarast med sista ansökningsdatumet 2021-01-31
Urval sker löpande, så skicka in din ansökan så snart som möjligt! Visa mindre