Senior Staff Regulatory Affairs Specialist

VB Spine

Remote, United States
Base: $135,000 – $145,000 annually; bonus/equity: ...
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6 years regulatory experience in medical devices
Fda and eu mdr regulatory framework knowledge
Lead complex regulatory projects and submissions
** VB Spine is seeking a Senior Staff Regulatory Affairs Specialist to drive regulatory strategies for innovative medical technology in a remote setting. The ideal candidate will have extensive regulatory experience, particularly in medical devices, and will be involved in shaping regulatory compliance and leading complex projects within a collaborative team environment. **

Job Summary

  • The role involves developing and updating global regulatory strategies for new product development and lifecycle management.
  • Candidates will advise leadership on regulatory requirements, risks, and strategies while monitoring evolving global landscapes.
  • The company offers competitive compensation ranging from $135,000 to $145,000 annually along with comprehensive health benefits.

Matching Summary

Match Score: 75

** VB Spine is seeking a Senior Staff Regulatory Affairs Specialist to drive regulatory strategies for innovative medical technology in a remote setting. The ideal candidate will have extensive regulatory experience, particularly in medical devices, and will be involved in shaping regulatory compliance and leading complex projects within a collaborative team environment. **

Salary

Base: $135,000 – $145,000 annually; Bonus/Equity: Potential for bonuses and incentives; Benefits: Comprehensive health, dental, vision, 401(k) match, PTO

Skills & Requirements

Must-have

  • 6 years regulatory experience in medical devices
  • FDA and EU MDR regulatory framework knowledge
  • Lead complex regulatory projects and submissions

Nice-to-have

  • RAC certification or advanced degree preferred
  • Mentor team members and cross-functional teams
  • Experience with external audits and acquisitions

Key Requirements

  • Bachelor's degree in Science, Legal, Regulatory, or Engineering
  • Minimum of 6 years of regulatory experience
  • Strong knowledge of FDA and EU MDR frameworks

Work Rights

Not specified

Tailored Resume

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