Medical Safety Manager, EI

🕒 July 30

🏈 Alabama, Alaska, +44 more states – Remote

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💵 $133k - $237k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 29%

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Logo of Philips

Philips

10,000+ employees

🏥 Healthcare

🔧 Hardware

💰 Post-IPO Equity - Philips on 2025-03

Healthcare • Hardware

Philips is a global health technology company (Koninklijke Philips N. V. ) that develops medical imaging systems (MR, CT, handheld ultrasound), patient monitoring and critical care solutions, and consumer health products such as Sonicare and the Pregnancy+ app. The company emphasizes delivering solutions that help clinicians provide faster, better care and also offers consumer-focused personal care and oral-health products. Philips positions itself around healthcare equipment, clinical informatics and connected care, and patient-facing health technologies.

📋 Description

• Conduct comprehensive evaluations of safety information from Post-Marketing Surveillance and literature searches • Contribute insights and recommendations to 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 input 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 • Must have an active clinical license; Nursing or MD strongly preferred • Strong knowledge of relevant medical device 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 • Excellent communication skills and ability to influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards • Must successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation • US work authorization required; candidates requiring sponsorship now or in the future will not be considered

🏖️ Benefits

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

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