Medical Safety Manager – Ultrasound

🔥 0 minutes ago

🍂 Massachusetts, Washington – Remote

🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $133k - $237k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Philips

WebsiteLinkedInAll Job Openings

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

• Independently conducts comprehensive safety evaluations using data from post-marketing surveillance, literature reviews, and clinical trials to proactively identify and assess potential risks and safety signals. • Provides critical safety insights and recommendations for risk management activities, including Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures, ensuring robust patient safety measures are in place. • Supports New Product Introduction, clinical studies, and post-marketing efforts by delivering safety-related perspectives and collaborating on safety inputs for regulatory submissions and key documentation such as RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports. • Responds to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust through transparent communication and supporting the implementation of safety policies, procedures, and programs to promote a culture of compliance. • Stays current with evolving medical product safety regulations and guidelines, offering input into the design and execution of safety studies and vigilance activities to ensure adherence to requirements throughout the product lifecycle.

🎯 Requirements

• 5+ years of experience with a bachelor’s degree or 3+ years experience with a master’s degree or higher in areas such as Medical/Clinical Affairs/Medical Safety in the Medical Device industry strongly preferred. • Prior bedside related clinical experience preferred. • Strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses and how to conduct them in a medical device environment. • Bachelor’s/master’s degree or higher in Medical Science, Nursing or equivalent. MD/PhD preferred. • Certified Professional in Patient Safety (CPPS) preferred.

🏖️ Benefits

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