Product Safety Risk Management Specialist

Philips UK

Gainesville, FL, United States
Base: $60,750 to $85,000 annually; bonus/equity: a...
Fully remote
Iso 14971 knowledge required
Medical device regulatory requirements
Product lifecycle risk assessment
This role is responsible for assisting in the development and documentation of the Philips central risk management process to ensure product safety

Job Summary

  • This role is responsible for assisting in the development and documentation of the Philips central risk management process to ensure product safety.
  • Candidates must possess in-depth knowledge of ISO 14971 and global medical device regulatory requirements such as FDA and MDR.
  • The position offers a comprehensive benefits package including a generous PTO, 401k match up to 7%, and stock purchase plans.

Matching Summary

This role is responsible for assisting in the development and documentation of the Philips central risk management process to ensure product safety.

Salary

Base: $60,750 to $85,000 Annually; Bonus/Equity: Annual incentive bonus, sales commission, or long-term incentives may be offered; Benefits: Generous PTO, 401k match, HSA, stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • ISO 14971 knowledge required
  • Medical device regulatory requirements
  • Product lifecycle risk assessment
  • Post-market surveillance data analysis
  • Risk management process maintenance

Nice-to-have

  • Software as a Medical Device experience
  • Hands-on software development background
  • Strong communication skills for reports
  • Community of Practice meeting support
  • Training material development experience

Key Requirements

  • Bachelor's Degree or Vocational Education
  • 4+ years technical experience in Medical Safety
  • US work authorization required (no sponsorship)
  • Reside in or near Gainesville FL

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter