Medical Safety Manager - Am&d

Philjobs

Base: $133,000 to $237,000; bonus/equity: annual i...
Fully remote
Safety surveillance activities
Post-marketing surveillance data analysis
Real-world evidence analysis
Philips is seeking a Medical Safety Manager for its Ambulatory Monitoring & Diagnostics division, responsible for overseeing safety surveillance activities for medical products. The ideal candidate will have significant experience in medical safety, strong regulatory knowledge, and effective communication skills

Job Summary

  • Independently conducts comprehensive safety evaluations using data from post-marketing surveillance, literature reviews, and clinical trials to proactively identify and assess potential risks and safety signals.
  • Supports New Product Introduction, clinical studies, and post-marketing efforts by delivering safety-related perspectives and collaborating on safety inputs for regulatory submissions and key documentation.
  • Stays current with evolving medical product safety regulations and guidelines, offering input into the design and execution of safety studies and vigilance activities to ensure adherence to requirements throughout the product lifecycle.

Matching Summary

Match Score: 85

Philips is seeking a Medical Safety Manager for its Ambulatory Monitoring & Diagnostics division, responsible for overseeing safety surveillance activities for medical products. The ideal candidate will have significant experience in medical safety, strong regulatory knowledge, and effective communication skills.

Salary

Base: $133,000 to $237,000; Bonus/Equity: Annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: Generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • Safety surveillance activities
  • Post-marketing surveillance data analysis
  • Real-world evidence analysis
  • Regulatory compliance support
  • Risk-Benefit Analyses preparation
  • Clinical Study Reports preparation
  • Clinical Evaluation Reports preparation

Nice-to-have

  • Excellent communicator
  • Ability to influence stakeholders
  • Culture of compliance promotion
  • Evolving regulations awareness

Key Requirements

  • 5+ years experience with bachelor's degree
  • 3+ years experience with master's degree or higher
  • Prior bedside clinical experience
  • Knowledge of medical device regulations
  • Knowledge of Health Hazard Evaluations
  • Knowledge of Issue Impact Assessments
  • Knowledge of Risk-Benefit Analyses
  • Bachelor's/master's degree in Medical Science, Nursing or equivalent
  • MD/PhD strongly preferred
  • Certified Professional in Patient Safety (CPPS) preferred

Work Rights

US work authorization required

Tailored Resume

Cover Letter