Medical Safety Manager – EI

🕒 June 17

🇺🇸 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 bolstering patient safety by contributing insights and recommendations to processes such as Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall procedures • Collaborate to furnish safety inputs for regulatory submissions and key documents ensuring compliance in safety evaluations • Conduct literature reviews and surveillance activities to identify emerging safety issues • Provide answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders • Contribute to safety-related policies, procedures, and programs to promote a culture of safety and compliance • Maintain awareness of evolving regulations and guidelines related to medical product safety • Analyze safety data from clinical trials and post-market surveillance to identify potential safety signals and trends

🎯 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 in a medical device environment • Bachelor’s/master’s degree in medical, Nursing, or equivalent. MD preferred • Ability to 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 • comprehensive Philips Total Rewards benefits program

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