Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
- Write, prepare, and manage regulatory submissions and filings required for U.S. FDA and other international authorities (i.e. 510(k), CE Marking, etc.)
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- Prepare documentation to support international registration dossiers and maintain product registration files and electronic databases.
- Act as core member on project teams to provide regulatory guidance and strategic regulatory planning in support of new product development and existing product support.
- Participate in inspections/audits by the notified body or other international regulatory agencies to include USDA by producing requested documents or answering any inquiries for information.
- Assist in the development of regulatory best practices, processes and procedures.
- Perform other duties as required.