Senior Medical Director, Integrated Medical Quality and Device Safety

📋 Description

• Perform medical assessment of product complaints, adverse events, and product quality issues to
• Lead evaluation of safety signals, adverse event trends, and emerging risks from post-market
• Contribute to and review Post-Market Surveillance System (PMSS) and Post-Market Clinical Follow-Up
• Provide medical expertise for Quality Risk Management (QRM) activities, including benefit-risk
• Serve as a medical safety expert accountable for Health Hazard Assessments (HHA) for quality and
• Provide medical input and oversight for Device Risk Management activities throughout the product

🎯 Requirements

• MD, DO, or equivalent medical degree with specialty residency and minimum 2 years of patient
• Minimum of 3 to 5 years of experience in drug safety, medical device safety, clinical development
• Strong understanding of global medical device regulations, including FDA, EU MDR, and other
• Experience evaluating complex safety signals and contributing to cross-functional risk assessments.
• Excellent written, verbal, and presentation communication skills.
• Experience with combination products and connected/digital medical devices.

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) plan
• Long-term incentive programs
• Base salary range: $182,000 - $346,000 (USD) per year