Regulatory Specialist Iii

PPD (Thermo Fisher)

Vantaa, Finland
On-site
Develop regulatory strategies
Global regulatory submissions
Ce marking technical files
Thermo Fisher is seeking a Regulatory Affairs Specialist III based in Vantaa, Finland, to provide strategic regulatory guidance for product development, registration, and lifecycle management. The ideal candidate will have experience in regulatory affairs, particularly within the pharmaceutical or medical device industries, and possess strong project management skills

Job Summary

  • Provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance.
  • Interact with Notified Bodies, FDA, & global regulatory authorities to gain alignment on regulatory strategies and resolve concerns to expedite approval of pending applications.

Matching Summary

Match Score: 85

Thermo Fisher is seeking a Regulatory Affairs Specialist III based in Vantaa, Finland, to provide strategic regulatory guidance for product development, registration, and lifecycle management. The ideal candidate will have experience in regulatory affairs, particularly within the pharmaceutical or medical device industries, and possess strong project management skills.

Skills & Requirements

Must-have

  • Develop regulatory strategies
  • Global regulatory submissions
  • CE marking technical files
  • Cross-functional team collaboration
  • Global regulatory policies
  • Interaction with regulatory authorities

Nice-to-have

  • Support regulatory staff development
  • Customer-focused mindset
  • Business acumen
  • Build consensus

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
  • Expert understanding of quality systems (ISO 13485, GMP/QSR)
  • Fluency in English required

Work Rights

Not specified

Tailored Resume

Cover Letter