Job ID :
Sweden - Uppsala
REGULATORY AFFAIRS MANAGER
Would you like to work at a world-leading life-science company? Where your work will have a real impact on the lives of people around the world? At Thermo Fisher Scientific’s ImmunoDiagnostics Division (IDD) headquarter in Uppsala, Sweden we develop, manufacture, and market complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,600 employees worldwide, IDD is the global leader in in-vitro allergy testing and also the European leader in autoimmunity diagnostics.
You will be joining a team of 14 Regulatory Affairs Managers, ten based at our Uppsala Headquarters and four 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 on 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 regulatory expert
- Review and approve product documentation
- Contribute to improved routines and processes for the Global Regulatory Affairs team
WHO ARE WE LOOKING FOR?
To succeed in this role you should have a positive attitude, be both service-minded and a good communicator. You should also have a sense of structure and accuracy and be able to plan and complete your work effectively.
We believe that the ideal candidate has:
- Several years of experience in global IVD or medical device product registrations
- Experience from Asian, East European and/or South American countries
- Experienced of regulatory aspects regarding marketing material and other product labeling
- Fluent Swedish and English, both spoken and written.
- A scientific (or similar) university degree
ARE YOUR INTERESTED?
Thermo Fisher Scientific is a constantly growing and changing organization, which means we can offer you an interesting and challenging position in an international environment.
We look forward to receiving your application – APPLY NOW AT http://jobs.thermofisher.com
If you have questions then please contact
Victoria Johansson (Senior Recruiter Nordics) email@example.com
Johanna Armstrand (Recruiter Sweden) firstname.lastname@example.org
Application deadline: 14 August 2017
THERMO FISHER SCIENTIFIC
THERMO FISHER SCIENTIFIC
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.