Regulatory Affairs Manager

How will you make an impact?
As a Regulatory Affairs Manager, you’ll be a part of making the world healthier, cleaner, and safer by helping patients around the world. 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 enable regulatory compliance and support the organization in understanding the requirements of the medical device products.
We are working in a LEAN-based environment, we wish you to be driven, creative and with your experience making 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 till you do?


Key Responsibilities
As part of our Regulatory Affairs team:
Lead and actively participate in product registration projects for defined global markets, incl. communication with internal and external partners.
Compile and submit the required documentation to obtain registration licenses.
Representing regulatory affairs in product development and product care projects, e.g. compiling regulatory assessments.
Issue, review and or approve product documentation.



How will you get there?
Minimum Requirements, Profile
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.
Essential ability to speak and write English on a professional level, independent understanding of Swedish.
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.
A minimum of three years’ experience in regulatory affairs management, such as compiling performance documentation for regulatory submissions with authorities for regulated medical device products.



Apply today! Welcome to apply with your CV and cover letter in English or Swedish at our career site http://jobs.thermofisher.com
Application deadline: December 7, 2020


If you have questions, please contact Madelene Holm, Recruiter Nordics, madelene.holm@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.


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 75,000 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. For more information, please visit www.thermofisher.com.


This position is based in Uppsala, where Thermo Fisher develop, 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, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics.