Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist III for their Vantaa, Finland location. The ideal candidate will oversee regulatory strategies for product development and registration within a collaborative, innovative environment
Job Summary
Provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across a diverse portfolio.
Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining compliance.
Interact with Notified Bodies, FDA, & global regulatory authorities to gain alignment on regulatory strategies and resolve concerns.
Matching Summary
Match Score: 85
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist III for their Vantaa, Finland location. The ideal candidate will oversee regulatory strategies for product development and registration within a collaborative, innovative environment.
Skills & Requirements
Must-have
global regulatory submissions
product technical files for CE marking
cross-functional team collaboration
regulatory strategy development
ISO 13485 and GMP/QSR knowledge
Nice-to-have
positive relationships with authorities
advise business unit regulatory teams
establish best practices and efficiencies
support regulatory staff development
Key Requirements
Advanced Degree plus 3 years of experience or Bachelor's Degree plus 5 years of experience in regulatory affairs
Strong knowledge of global regulatory requirements (FDA, EU MDR/IVDR)
Experience preparing and submitting regulatory filings