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. In a senior position of the Quality and Regulatory team, 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.
What till you do?
Key Responsibilities:
Lead and actively participate in product registration projects for defined global markets, incl. communication with internal and external partners.
Compile and submit 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.
Capability to issue and deliver technical product documentation for regulatory purposes.
A minimum of 5 years’ experience of regulatory affairs management, such as compiling performance documentation for regulatory submissions with authorities for regulated medical device products.

Apply today at our career site http://jobs.thermofisher.com.
Combine your CV and Cover letter (in Swedish or English) in one attachment and attach it to the first step of the application.
Application deadline: Sept 14, 2020.The position can be closed before the application deadline.
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 is the world leader in serving science, with annual revenue exceeding $25 billion. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.
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.