Medical Safety Manager – EI

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $133k - $237k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

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Philips

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

• Conduct comprehensive evaluations of safety information sourced from various channels • Provide essential support in Risk Management, Health Hazard Evaluations (HHE), and recall procedures • Assist in delivering safety-related perspectives for New Product Introduction (NPI) projects and clinical studies • Analyze safety data from clinical trials and post-market surveillance • Provide answers to safety-related inquiries from healthcare professionals and internal stakeholders

🎯 Requirements

• 7+ years of experience in Medical/Clinical affairs in Medical Device/Biotech industry or equivalent • Active clinical license (Nursing or MD strongly preferred) • Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.) • Strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses • Bachelor’s/master’s degree in medical, Nursing, or equivalent (MD preferred) • Excellent communicator with ability to influence cross-functional stakeholders

🏖️ Benefits

• Generous PTO • 401k (up to 7% match) • HSA (with company contribution) • Stock purchase plan • Education reimbursement

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