Medical Safety Manager

🕒 June 17

🏈 Alabama, Alaska, +42 more states – Remote

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💵 $133k - $237k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

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👻 Ghost score 45%

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Logo of Philips

Philips

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare • Healthcare Insurance • Biotechnology

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 from Post-Marketing Surveillance and literature searches • Support Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall procedures • Provide safety perspectives for New Product Introduction projects, clinical studies, and Post-Marketing Surveillance efforts • Provide safety inputs for regulatory submissions, Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports • Conduct literature reviews and surveillance activities to identify emerging safety issues • Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders • Contribute to safety-related policies, procedures, and programs • Maintain awareness of evolving medical product safety regulations and guidelines • Provide input into safety studies and medical device vigilance activities • Analyze clinical trial and post-market surveillance data to identify safety signals and trends

🎯 Requirements

• 7+ years of experience in Medical/Clinical affairs in the Medical Device/Biotech industry or equivalent • Active clinical license required; Nursing or MD strongly preferred • Strong knowledge of relevant medical device industry standards and regulations, including ISO and IEC • Strong knowledge 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 meet minimum physical, cognitive, and environmental job requirements with or without accommodation • Excellent communication skills and ability to influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards • US work authorization required • Must not require sponsorship for a work-authorized visa now or in the future

🏖️ Benefits

• Annual incentive bonus may be offered • Sales commission may be offered • Long-term incentives may be offered • Generous PTO • 401k with up to 7% match • HSA with company contribution • Stock purchase plan • Education reimbursement • Philips Total Rewards benefits program

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