Regulatory Specialist Iii

PPD (Thermo Fisher) UK

Vantaa, Finland
Global regulatory requirements knowledge
Fda and eu mdr/ivdr expertise
Technical file preparation for ce marking
The role involves providing strategic regulatory guidance for product development, registration, and lifecycle management across a diverse portfolio

Job Summary

  • The role involves providing strategic regulatory guidance for product development, registration, and lifecycle management across a diverse portfolio.
  • Candidates will act as the company representative to maintain positive relationships with global authorities like the FDA and Notified Bodies.
  • The position requires overseeing regulatory communications with marketing to ensure appropriate approval of commercial literature and language.

Matching Summary

The role involves providing strategic regulatory guidance for product development, registration, and lifecycle management across a diverse portfolio.

Skills & Requirements

Must-have

  • Global regulatory requirements knowledge
  • FDA and EU MDR/IVDR expertise
  • Technical file preparation for CE marking
  • Cross-functional team collaboration
  • Change order review and approval

Nice-to-have

  • Strong analytical and problem-solving capabilities
  • Experience supporting staff development
  • Fluency in additional languages
  • Proactive relationship building with authorities
  • Customer-focused mindset with business acumen

Key Requirements

  • Advanced Degree plus 3 years experience or Bachelor's plus 5 years
  • Experience in pharmaceutical, medical device, or diagnostics industry
  • RAC certification advantageous
  • Fluency in English required

Work Rights

Not specified

Tailored Resume

Cover Letter