Medical Safety Manager – Complaints Handling

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $133k - $237k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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Philips

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

Philips is a global health technology company committed to improving people's health and well-being through meaningful innovation. They focus on various domains including personal health, diagnosis and treatment, and connected care, striving to provide advanced technologies and solutions that enhance health outcomes for individuals and healthcare providers alike.

📋 Description

• Accountable for preliminary clinical assessments for issues alleging injury or death for Philips products • providing input for Issue Impact Assessments/HHED • Perform clinical assessments for Philips products involving injury or death allegations, contribute to Issue Impact Assessments/HHED, and ensure prompt escalation and resolution of complex complaints • Participate in governance meetings, provide clinical insights for consistent decision-making, and serve as a subject matter expert in post-market surveillance activities to ensure regulatory compliance and patient safety • Evaluate and improve post-market surveillance processes, collaborate with global complaint handling and correction teams, and drive solutions to address gaps and enhance efficiency • Communicate post-market clinical insights across businesses, markets, functions, and suppliers to support continuous improvement in complaint handling and corrections and removals for Philips products • Support compliance with global regulations and internal quality standards, implement and refine operational processes for clinical input, and contribute to recruiting, developing, and coaching talent within the team

🎯 Requirements

• 10+ years of experience in Medical Safety/Medical Affairs Risk Management in the Medical Device industry • Prior hands-on bedside/clinical experience required • 4+ years of post-market experience required • familiarity with CFR, EUMDR, ISO standards, etc. • Experience with Issue Impact Assessments, Health Hazard Evaluations, and Risk Benefit Analyses is preferred but not required • bachelor’s/master’s degree in medical science, Nursing, Respiratory Therapy or equivalent • Certified Professional in Patient Safety (CPPS) preferred • Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation

🏖️ Benefits

• generous PTO • 401k (up to 7% match) • HSA (with company contribution) • stock purchase plan • education reimbursement