Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and support market access for our innovative diagnostic solutions
Job Summary
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and support market access for our innovative diagnostic solutions.
This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.
You'll work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management system.
Matching Summary
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and support market access for our innovative diagnostic solutions.
Skills & Requirements
Must-have
Regulatory submissions management
Quality management system support
Product compliance assurance
Nice-to-have
Cross-functional team collaboration
Regulatory intelligence assessment
Strong analytical skills
Key Requirements
Advanced Degree or Bachelor's Degree plus 2 years of experience
Comprehensive knowledge of FDA and EU IVDR
Strong understanding of quality management systems