Medical Safety Manager – Complaints Handling

🕒 vor 1 Tag

🇺🇸 Vereinigte Staaten – Remote

💵 $133.000 - $237.000 / Jahr

⏰ Vollzeit

🟠 Senior

🔴 Experte

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Philips

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10.000+ Mitarbeiter

⚕️ Krankenversicherung

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical Devices

Im Laufe des vergangenen Jahrzehnts haben wir uns zu einem führenden Unternehmen mit klarem Fokus auf Gesundheitstechnologie entwickelt.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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