Sr. Manager Post Market Quality

BD

San Diego, CA, USA
Base: $158,300.00 - $261,100.00 usd annual; bonus/...
10+ years fda regulated environment experience
Expertise in iso 13485 and 21 cfr part 7/806
End-to-end field action process management
The role is accountable for the end-to-end field action process within North America while aligning with global regional representatives

Job Summary

  • The role is accountable for the end-to-end field action process within North America while aligning with global regional representatives.
  • Candidates must demonstrate comprehensive expertise in interpreting worldwide regulatory standards applicable to the medical device industry.
  • The position offers a competitive salary range of $158,300.00 to $261,100.00 USD annually along with a comprehensive Total Rewards program.

Matching Summary

The role is accountable for the end-to-end field action process within North America while aligning with global regional representatives.

Salary

Base: $158,300.00 - $261,100.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program

Skills & Requirements

Must-have

  • 10+ years FDA regulated environment experience
  • Expertise in ISO 13485 and 21 CFR Part 7/806
  • End-to-end field action process management
  • Field Action Committee leadership and facilitation
  • Regulatory reporting including GRIA and 806 reports

Nice-to-have

  • Prior BD company experience preferred
  • Experience with Class II and III medical devices
  • Strong influence and coaching capabilities
  • Process excellence and continuous improvement mindset
  • Data analytics for post-market risk assessment

Key Requirements

  • BA/BS degree in Life Science or Engineering; MBA preferred
  • Minimum 10 years in quality & regulatory management
  • FDA Class II and Class III medical device experience
  • Knowledge of product failure modes and audit support

Work Rights

Not specified

Tailored Resume

Cover Letter