Post-market Risk Management Manager

BD

San Diego, CA, USA
Base: $126,600.00 - $208,900.00 usd annual; bonus/...
Fully remote
Iso 14971 compliant risk management files
Fda 21 cfr 820 regulatory knowledge
5 years post-market quality experience
The role is responsible for implementing and ensuring compliance with design control and risk management requirements throughout the life cycle of BD's dispensing medical devices

Job Summary

  • The role is responsible for implementing and ensuring compliance with design control and risk management requirements throughout the life cycle of BD's dispensing medical devices.
  • Candidates must lead cross-functional teams during design development and post-market risk management reviews to ensure all necessary activities align with the quality system.
  • BD offers a culture that values on-site collaboration, requiring a minimum of 4 days in-office presence per week to foster creativity and effective problem-solving.

Matching Summary

The role is responsible for implementing and ensuring compliance with design control and risk management requirements throughout the life cycle of BD's dispensing medical devices.

Salary

Base: $126,600.00 - $208,900.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture and competitive package

Skills & Requirements

Must-have

  • ISO 14971 compliant risk management files
  • FDA 21 CFR 820 regulatory knowledge
  • 5 years post-market quality experience
  • FMEA process implementation and remediation
  • Cross-functional team leadership skills

Nice-to-have

  • Strong oral and written communication skills
  • Ability to adapt to rapidly changing environment
  • Desire to contribute to innovative products
  • Experience mentoring cross-functional teams
  • Strategic planning and continuous improvement mindset

Key Requirements

  • Bachelor's degree in engineering
  • Minimum 5 years Quality/Design Controls/Risk Management experience
  • Minimum 5 years Post-Market Quality experience
  • Two years of people management experience
  • Advanced knowledge of ISO 13485 and FDA regulations

Work Rights

Not specified

Tailored Resume

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