Job Title: Senior Regulatory Affairs Officer
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work that supports a powerful mission. With revenues of $17 billion and a track record of stability and consistent growth, we’re uniquely able to give our people the resources and opportunities to make significant contributions to the world.
The primary purpose of the role is to ensure that the Thermo Fisher Scientific Microbiology Division site at Dartford fulfills the applicable regulatory requirements necessary to place products on the market in a compliant manner to applicable regulations. The position holder will report into the RA Manager (Europe). The role has no budgetary or line management responsibilities.
- Be the primary RA representative for the Immunodiagostics products for which Dartford has responsibility as well as RA responsibility for distribution activities of other MBD products that are distributed from the Dartford site
- Develop and deploy global regulatory strategies and manage the pre-market submission of the Immunodiagostics products as well as assist with the registration of Dartford-distributed products as necessary
- Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life-cycle management of products
- Be responsible for the planning and implementation of new and updated regulations as applicable to Dartford products while working in coordination with global regulatory affairs
- Assist Line Manager in gathering relevant KPI and metrics
- Lead change projects and site quality review meetings
- Bachelors or Masters degree in Science preferably in the Biological Sciences or Regulatory Affairs
- Proven experience in regulatory affairs in IVD or medical devices companies. Regulatory Affairs Certified individual preferred.
- Ability to make balance decisions in relation to business/customer requirements and offer appropriate advice
- Ability to work with minimal supervision with sound technical judgment and analytical skills in a highly matrixed business environment
- Ability to coordinate and manage the completion of multiple projects simultaneously
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to travel within UK and internationally as required
Non-Negotiable Hiring Criteria:
- Proven experience in RA in IVD or medical devices companies
- Experienced in submission or Technical File compilation
- Strong project management and organisational skills
- Demonstrated experience in navigating complex pre-market submissions.
- Experience working in a broader enterprise/cross-division business unit model preferred