When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Description |
The Senior Regulatory Affairs Specialist obtains medical device pre-market regulatory approvals and necessary domestic listings to ensure global market access is realized for products and services. The Senior Regulatory Affairs Specialist authors and maintains regulatory submission in the US, Canada, Europe and works through third party entities in the rest of the world. The Specialist’s work can include providing Regulatory Affairs support on new product development projects. This individual must be vigilant of developing standards and regulations and their impact on product regulatory status. In addition, the RA Specialist will also handle post-market agency reporting activities i.e. Medical Device Reports, Correction & Removal Reporting and Post Market Surveillance. Responsibilities:
Requirements:
At Thermo Fisher Scientific, each one of our 55,000 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. *IND-LPG |