Company: PHADIA AB
Location: Uppsala



Job DescriptionREGULATORY AFFAIRS MANAGERUPPSALA 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. With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world Division and Location specific information The Global Regulatory Affairs (RA) Department at our ImmunoDiagnostics Division (IDD) is growing and we are therefore looking for a Regulatory Affairs Manager in Uppsala. You will be joining a team of approximately 19 people who work with Regulatory Affairs questions; twelve based at our Uppsala Headquarters and seven at our Freiburg site.

The ImmunoDiagnostics division in Thermo Fisher Scientific develops, manufactures and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. How will you make an impact? For more than 40 years, we have been focused on delivering results, and we are proud to report that, in that time, we have maintained leadership in allergy testing and become one of the world’s leading allergy and autoimmune disease test providers.In this role you be joining one or the world’s largest life-science companies and will be able to help people around the world with allergies and autoimmune diseases to lead healthier lives. What will you do?Lead and actively participate in product registration projects on defined global marketsCompile and submit required documentation to obtain registration licensesCommunicate with internal and external partners and with regulatory authorities in specified countriesParticipate in product development as regulatory expertReview and approve product documentationContribute to improved routines and processes for the Global Regulatory Affairs teamHow will you get there?

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 registrationExperienced of regulatory aspects regarding marketing material and other product labelingFluent Swedish and English, both spoken and written.A scientific (or similar) university degree At Thermo Fisher Scientific, each one of our 70,000 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.

Apply today! The selection process is on-going, please apply as soon as possible.Please note, due to SUMMER HOLIDAY you will not be able to contact Charlotta or Victoria between the 15th July – 12th AugustVictoria Johansson (Senior Recruiter Nordics) Charlotta Bitzen-Hermodsson (Director Global Regulatory Affairs, ImmunoDiagnostics Division) Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.