Role Description The Medical Safety Manager independently oversees safety surveillance activities for medical products by analyzing data from post-marketing surveillance, literature reviews, and real-world evidence to identify risks and ensure patient well-being. The role supports regulatory compliance through the preparation of safety-related documentation, including Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports.

• 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.

Qualifications

• 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 Respiratory Therapist experience is required.
• Experience with human factors is preferred but not required.
• Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
• Strong working 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.
• Must be a Registered Respiratory Therapist (RRT).
• Excellent communicator with an ability to influence cross-functional stakeholders utilizing clinical expertise and knowledge of standard of care and medical device standards.

Requirements

• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Benefits

• Eligible to participate in comprehensive Philips Total Rewards benefits program.
• Generous PTO.
• 401k (up to 7% match).
• HSA (with company contribution).
• Stock purchase plan.
• Education reimbursement.
• Additional compensation may include an annual incentive bonus, sales commission, or long-term incentives.