Medical Safety Manager - EI

About the role

The Medical Safety Manager, Enterprise Informatics (EI) is responsible for evaluating safety information from various sources and providing insights and recommendations to support patient safety initiatives.

Responsibilities

• Conduct comprehensive evaluations of safety information from Post-Marketing Surveillance (PMS) and literature searches.
• Contribute to risk management, HHE, RBA, and recall procedures.
• Deliver safety-related perspectives for NPI projects, clinical studies, and PMS efforts.
• Furnish safety inputs for regulatory submissions and key documents like RBA, protocols, CSR, and CERs.
• Identify emerging safety issues through literature reviews and surveillance activities.
• Provide answers to safety-related inquiries and foster trust in communication.
• Implement safety-related policies, procedures, and programs to promote a culture of safety and compliance.
• Stay updated on evolving regulations and guidelines and ensure compliance.
• Conduct safety studies and medical device vigilance activities to ensure robust safety surveillance.
• Analyze safety data from clinical trials and post-market surveillance to identify potential safety signals and trends.

Requirements

• 7+ years of experience in Medical/Clinical affairs in Medical Device/Biotech industry or equivalent.
• Active clinical license (Nursing or MD preferred).
• Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
• 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 perform physical, cognitive, and environmental job requirements with or without accommodation.
• Excellent communication skills to influence cross-functional stakeholders.

Qualifications

• Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
• Experience in conducting Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses.
• Understanding of clinical trial and post-market surveillance data analysis.
• Ability to communicate effectively with healthcare professionals, patients, and internal stakeholders.

Skills

• Expertise in medical device industry standards and regulations.
• Strong analytical and problem-solving skills.
• Effective communication and influencing skills.
• Knowledge of clinical trial and post-market surveillance data analysis.

Benefits

Philips offers a comprehensive benefits package including:

• Generous PTO
• 401(k) with company match up to 7%
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement
• and much more.

Pay

The pay range for this position varies based on location and qualifications. Please refer to the pay range details for your specific location.

Schedule

This is a field-based role requiring at least 3 days per week of in-office presence.

Contact

To apply, please visit our careers page and submit your application. Interested candidates are encouraged to apply as soon as possible.