Medical Safety Manager, Ambulatory Monitoring & Diagnostics

Philips

1d • $133,000 - $237,000 • Onsite

About The Position

The Medical Safety Manager independently oversees safety surveillance activities for medical products, analyzing post-marketing surveillance data, literature reviews, clinical-trial data, and real-world evidence to identify risks and safety signals and protect patients. The role supports regulatory compliance through safety-related documentation, including Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports.

The position provides safety perspectives for New Product Introduction, clinical studies, and post-marketing activities; advises on risk management, Health Hazard Evaluations, and recall procedures; and responds to safety inquiries from healthcare professionals, patients, and internal stakeholders. It also contributes to safety policies, procedures, studies, and vigilance activities as regulations and guidelines evolve.

This is a field-based role. The position requires residence in or within commuting distance of the posted locations. US work authorization is required, and relocation benefits are not provided.

Requirements

• At least 5 years of experience with a bachelor's degree, or at least 3 years of experience with a master's degree or higher.
• Experience in areas such as Medical Affairs, Clinical Affairs, or Medical Safety; medical device industry experience is strongly preferred.
• Prior bedside-related clinical experience is required.
• Strong knowledge of relevant medical device standards and regulations, including ISO and IEC standards.
• Strong knowledge of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses, including how to conduct them in a medical device environment.
• A bachelor's, master's, or higher degree in Medical Science, Nursing, or an equivalent field.
• Ability to communicate effectively and influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards.
• Ability to meet the position's minimum physical, cognitive, and environmental job requirements, with or without accommodation.
• US work authorization; candidates requiring work-authorized visa sponsorship now or in the future will not be considered.
• Must reside in or within commuting distance of posted locations.

Nice To Haves

• Medical device industry experience.
• MD or PhD.
• Related specialized clinical experience.
• Certified Professional in Patient Safety (CPPS).

Responsibilities

• Independently conduct safety evaluations using post-marketing surveillance, literature reviews, and clinical-trial data to identify and assess potential risks and safety signals.
• Provide safety insights and recommendations for risk management, including Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures.
• Support New Product Introduction, clinical studies, and post-marketing efforts with safety perspectives and regulatory-submission inputs.
• Contribute to safety documentation, including Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports.
• Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders.
• Support implementation of safety policies, procedures, and programs and promote a culture of compliance.
• Monitor changes in medical product safety regulations and guidelines and provide input into safety studies and vigilance activities.

Benefits

• Generous paid time off.
• 401(k) with up to 7% company match.
• Health Savings Account (HSA) with company contribution.
• Stock purchase plan.
• Education reimbursement.
• Other benefits through the Philips Total Rewards benefits program.
• An annual incentive bonus, sales commission, or long-term incentives may also be offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager