Director, Regulatory Affairs (hybrid)

Spectrumvascular

Hybrid
**
Hands-on authoring of 510(k) submissions
Direct interaction with fda and notified bodies
Expertise in iso 14971 risk management
** Spectrum Vascular is seeking a Director of Regulatory Affairs to lead regulatory activities for their medical device portfolio. The ideal candidate should possess extensive regulatory experience, particularly in authoring 510(k) submissions, and demonstrate a strategic yet hands-on approach to compliance. **

Job Summary

  • Spectrum Vascular is an innovative medical device company focused on vascular access and medication management with a mission to improve patient lives globally.
  • The Director will serve as the primary regulatory lead responsible for strategic direction and hands-on execution of complex submissions like 510(k)s and PMAs.
  • This role requires a blend of strategic oversight and tactical execution within a fast-paced, entrepreneurial team culture.

Matching Summary

Match Score: 75

** Spectrum Vascular is seeking a Director of Regulatory Affairs to lead regulatory activities for their medical device portfolio. The ideal candidate should possess extensive regulatory experience, particularly in authoring 510(k) submissions, and demonstrate a strategic yet hands-on approach to compliance. **

Skills & Requirements

Must-have

  • Hands-on authoring of 510(k) submissions
  • Direct interaction with FDA and Notified Bodies
  • Expertise in ISO 14971 risk management
  • Strategic oversight of global product registrations
  • Experience with design controls and lifecycle management

Nice-to-have

  • Mentoring junior regulatory staff
  • Entrepreneurial mindset in dynamic environment
  • Continuous improvement of regulatory processes
  • Ability to navigate ambiguous regulatory pathways

Key Requirements

  • 8-10+ years regulatory affairs experience in FDA-regulated industry
  • Bachelor's degree in Engineering or Life Sciences required
  • Advanced degree preferred
  • Proven track record authoring complex regulatory submissions

Work Rights

Not specified

Tailored Resume

Cover Letter