Manager Regulatory Affairs
Phadia AB / Administratörsjobb / Uppsala
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hela Sverige Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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 90,000 colleagues delivers an unrivalled 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. For more information, please visit
www.thermofisher.com. This position is based in Uppsala, where Thermo Fisher develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,900 employees worldwide working with these products, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics. Together there are 90 000 employees working for Thermo Fisher Scientific globally.
How will you make an impact?
As the Manager Regulatory Affairs, you will join our Quality and Regulatory team in Uppsala, which is the headquarters for our global business within Immunodiagnostics. In this role, you are responsible for activities that support the compliance, registration, maintenance, and promotion of existing and new product rollouts and secure our patient's safety.
You will enable regulatory compliance and support the organization in understanding the requirements of the medical device products.
We are working in a LEAN-based environment, and we wish you to be driven, creative and with your experience make improvements within our team and across teams, in close cooperation with RnD, Marketing, Production, QA and other key functions under the same roof.
Please watch the video "Why quality is important to us at Thermo Fisher Scientific"
https://www.youtube.com/watch?v=h69rLkHHPoE What will you do?
You will be a key player in business-critical projects, leading a small team in developing regulatory strategies, GAP analyses, regulatory assessments, and working tightly together with regional Regulatory Affairs managers, as well as internal colleagues, to ensure compliance for our instruments, software's and systems.
As part of our Regulatory Affairs team and leader of the Regulatory Systems group that includes software and instruments you will also:
• Lead and actively participate in product registration projects for defined global markets, incl. communication with internal and external partners.
• Be the SME for instruments and software products
• Define and implement registration strategies
• Compile and submit the required documentation to obtain registration licenses.
• Represent regulatory affairs in product development and product care projects, e.g. compiling regulatory assessments.
• Issue, review and or approve product documentation.
• Review and define requirements related to product information such as product labels and Instructions for Use
• Support the organization in Regulatory Affairs related questions, including regulatory assessments within product care activities, change requests, and new registrations
What do you need?
• A university degree or equivalent in a relevant technical subject (e.g. engineering or chemistry).
• Ability to work independently, taking responsibility for the management of processes, projects and timelines.
• Skilled to work across departments, in a matrix organization.
• Previous experience from a regulated work environment, preferably within the medical device or diagnostic industry.
• Capability to issue and deliver technical product documentation for regulatory purposes.
• Experience in regulatory affairs management, such as compiling performance documentation for regulatory submissions with authorities for regulated medical device products.
• Experience in people management
• Fluent in Swedish and English, both spoken and written
Please send in your application, including a cover letter, CV (in one document) in English, apply via
http://jobs.thermofisher.com/ by 6th December 2021. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.
If you have questions, then please contact:
Nina Albuquerque, Sr Recruiter Nordics on
nina.albuquerque@thermofisher.comApply today!
http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of sex, transgender identity or expression, ethnicity, religion or other belief, disability, sexual orientation or age.
Publiceringsdatum2021-11-23Så ansöker duSista dag att ansöka är 2021-12-12
Klicka på denna länk för att göra din ansökanAdressPhadia AB
RAPSGATAN 7
75137 UPPSALA
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Phadia AB (org.nr 556041-3204)
Rapsgatan 7 (
visa karta)
751 37 UPPSALA
Arbetsplats Phadia AB
Jobbnummer 6125746
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