Medical Safety Manager Complaints Handling

Accountabilities

• Perform clinical evaluations of post-market complaints involving injury or death, determining harm severity, supporting IMDRF coding, and contributing to regulatory reportability assessments.
• Provide expert clinical input for Issue Impact Assessments and Health Hazard Evaluations, ensuring timely escalation and resolution of complex safety cases.
• Serve as a key liaison between Medical Safety and Post-Market Surveillance teams to ensure alignment in complaint handling and risk assessment decisions.
• Participate in governance forums and cross-functional discussions, delivering clinical insights to support consistent, evidence-based decision-making.
• Drive continuous improvement of post-market surveillance processes by identifying gaps, collaborating on corrective actions, and enhancing operational efficiency.
• Support global compliance efforts by ensuring adherence to regulatory standards and internal quality requirements across complaint handling activities.
• Contribute to the mentoring, coaching, and development of team members within the medical safety function.

Requirements

• 10+ years of experience in Medical Safety, Medical Affairs, or Risk Management within the Medical Device industry.
• Prior hands-on clinical or bedside experience is required, along with at least 4+ years in post-market surveillance or complaint handling roles.
• Bachelor’s or Master’s degree in Nursing, Medical Science, Respiratory Therapy, or a related healthcare field.
• Strong knowledge of global regulatory frameworks including CFR, EU MDR, and applicable ISO standards.
• Experience with or exposure to Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analysis is highly preferred.
• Excellent cross-functional communication skills with the ability to influence stakeholders in a global, matrixed environment.
• Strong analytical thinking, clinical judgment, and decision-making capabilities in high-impact safety scenarios.
• Certified Professional in Patient Safety (CPPS) is a plus.

Benefits

• Competitive annual salary ranging from $133,000 to $237,000 , depending on location, experience, and qualifications
• Annual incentive bonus and eligibility for long-term incentive programs
• Comprehensive health coverage including medical, dental, and vision insurance
• 401(k) retirement plan with up to 7% company match
• Health Savings Account (HSA) with company contributions
• Generous paid time off and flexible vacation policies
• Stock purchase plan and education reimbursement programs
• Access to a global, mission-driven environment focused on healthcare innovation and patient safety
• Comprehensive Total Rewards program including wellness and employee support benefits

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