Medical Safety Manager – Complaints Handling

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

📋 Description

• Responsible for the initial clinical evaluations regarding claims of injury or fatality related to Philips products.

• Providing contributions for Issue Impact Assessments and Health Hazard Evaluations (HHED).

• Conduct clinical assessments for Philips products that involve allegations of injury or death, participate in Issue Impact Assessments/HHED, and ensure the swift escalation and resolution of intricate complaints.

• Engage in governance meetings, offer clinical insights for uniform decision-making, and act as a subject matter expert in post-market surveillance efforts to guarantee regulatory adherence and patient safety.

• Assess and enhance post-market surveillance methodologies, work in partnership with global complaint handling and correction teams, and implement solutions to address deficiencies and boost efficiency.

• Share post-market clinical insights across various businesses, markets, functions, and suppliers to facilitate ongoing improvements in complaint management and corrective actions for Philips products.

• Assist in ensuring compliance with global regulations and internal quality benchmarks, refine operational processes for clinical input, and aid in the recruitment, development, and mentoring of team members.

⛳️ Requirements

• Over 10 years of experience in Medical Safety or Medical Affairs Risk Management within the Medical Device sector.

• Previous direct bedside or clinical experience is necessary.

• A minimum of 4 years of experience in post-market activities is required.

• Knowledge of CFR, EUMDR, ISO standards, etc., is essential.

• Experience with Issue Impact Assessments, Health Hazard Evaluations, and Risk Benefit Analyses is preferred, but not mandatory.

• A bachelor’s or master’s degree in medical science, Nursing, Respiratory Therapy, or a related field is required.

• Certification as a Professional in Patient Safety (CPPS) is preferred.

• Must be capable of successfully meeting the minimum physical, cognitive, and environmental job requirements, with or without accommodations.

🏝️ Benefits

• Generous paid time off (PTO).

• 401k plan with up to 7% company match.

• Health Savings Account (HSA) with company contributions.

• Stock purchase plan.

• Education reimbursement.