REGULATORY AFFAIRS MANAGER

THERMO FISHER SCIENTIFIC

As a world leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 17 billion in annual revenue. 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.

REGULATORY AFFAIRS MANAGER UPPSALA

The Global Regulatory Affairs Department at our ImmunoDiagnostics Division (IDD) is growing and we are therefore looking for an experienced Regulatory Affairs Manager in Uppsala. IDD develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,500 employees worldwide, IDD is the global leader in in-vitro allergy testing and also the European leader in autoimmunity diagnostics.

THE POSITION

You will be joining a team of 14 Regulatory Affairs Managers, 10 based at our Uppsala Headquarters and 4 at our Freiburg site. We are looking for someone with an eye for detail who has several years of experience of IVD or medical device regulatory affairs.

Your main responsibilities will be to:
. Lead and actively participate in product registration projects for defined global markets.
. Compile and submit required documentation to obtain registration licenses.
. Communicate with internal and external partners and with regulatory authorities in specified countries.
. Participate in product development as a regulatory expert.
. Review and approve product documentation.
. Contribute to improved routines and processes for the Global Regulatory Affairs team.

WHO ARE WE LOOKING FOR?

The ideal candidate will have:
. Several years of experience of global IVD or medical device product registrations. Experience from Asian, East European and/or South American countries is a plus.
. Experience of regulatory aspects related to marketing material and other product labeling
. Fluent Swedish and English, both spoken and written.
. A University degree in a scientific or similar subject area.
. A positive attitude and be service minded and work in a structured way with a focus on accuracy.

IS THIS THE OPPORTUNITY FOR YOU?

The Global Regulatory Affairs team offers excellent opportunities personal development within the field. When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best.

If you have questions then please contact Victoria Johansson (Senior Recruiter Nordics) victoria.johansson@thermofisher.com or 0046 723028514

Application deadline: 9th October 2016

At Thermo Fisher Scientific, each one of our 50,000 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.