Regulatory Affairs Specialist II
Thermo Fisher ScientificWhat You'll Do
Ensure product compliance and market access for innovative diagnostic solutions. Manage regulatory submissions and maintain product registrations. Support quality management systems across global markets.
What We're Looking For
Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in IVD/medical device industry. Comprehensive knowledge of global regulatory requirements, particularly FDA, EU IVDR/MDR, and regional regulations.
What We Offer
This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.
Key Skills & Technologies
Additional Information
Experience Level
Mid-Level
Job Language
English
Employment Type
Full-time
Work Mode
Remote