Medical Safety Manager – EI

This is a fully remote position, open to applicants in United States.

📋 Description

• Perform thorough evaluations of safety information gathered from multiple sources.

• Offer vital support in enhancing patient safety by providing insights and recommendations for processes such as Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall procedures.

• Collaborate to provide safety inputs for regulatory submissions and essential documents, ensuring compliance in safety evaluations.

• Execute literature reviews and surveillance activities to detect emerging safety concerns.

• Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders.

• Aid in the development of safety-related policies, procedures, and programs to foster a culture of safety and compliance.

• Stay informed about changing regulations and guidelines concerning medical product safety.

• Analyze safety data from clinical trials and post-market surveillance to identify potential safety signals and trends.

⛳️ Requirements

• Over 7 years of experience in Medical/Clinical affairs within the Medical Device/Biotech industry or a similar field.

• Active clinical license (Nursing or MD strongly preferred).

• In-depth knowledge of relevant standards and regulations applicable to the medical device industry (ISO, IEC, etc.).

• Comprehensive understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses in a medical device context.

• Bachelor’s or master’s degree in medical, Nursing, or a related field. MD preferred.

• Capability to meet the minimum Physical, Cognitive, and Environmental job requirements, with or without accommodation.

🏝️ Benefits

• Generous PTO.

• 401k (up to 7% match).

• HSA (with company contribution).

• Stock purchase plan.

• Education reimbursement.

• Comprehensive Philips Total Rewards benefits program.