Director, Regulatory Affairs

Thermo Fisher Scientific UK

Virginia, United States
Base: $175,000.00–$219,000.00; bonus: variable ann...
8-10 years ivd regulatory experience
Fda and global health authority knowledge
Multi-site multi-national team leadership
This role involves leading strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions

Job Summary

  • This role involves leading strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions.
  • The position offers a comprehensive Total Rewards package including national medical plans, tuition reimbursement, and competitive retirement savings.
  • Candidates will shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance.

Matching Summary

This role involves leading strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions.

Salary

Base: $175,000.00–$219,000.00; Bonus: Variable annual bonus based on performance; Benefits: Comprehensive medical, dental, vision, 401(k), PTO, and parental leave

Skills & Requirements

Must-have

  • 8-10 years IVD regulatory experience
  • FDA and global health authority knowledge
  • Multi-site multi-national team leadership
  • Regulatory submission and agency interaction
  • Strategic regulatory planning and implementation

Nice-to-have

  • Fluency in additional languages
  • Active participation in professional associations
  • Experience with OEM business partners
  • Knowledge of current industry trends
  • Strong negotiation and influencing skills

Key Requirements

  • Advanced Degree plus 8 years or Bachelor's plus 10 years experience
  • Life Sciences, Pharmacy, Chemistry, or Microbiology degree preferred
  • Demonstrated expertise in quality management systems
  • Ability to travel 25-50% internationally
  • Fluency in English required

Work Rights

Not specified

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