Medical Safety Manager Complaints Handling
New
Based in the United StatesFull-TimeManager
Salary$133,000 to $237,000
Apply NowOpens the employer's application page
Job Details
- Experience
- 10+ years of experience in Medical Safety, Medical Affairs, or Risk Management within the Medical Device industry; 4+ years in post-market surveillance or complaint handling
- Required Skills
- Risk Management
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.
- 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.
- 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.
- Certified Professional in Patient Safety (CPPS) is a plus.
Responsibilities
- 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.
View Full Description & ApplyYou'll be redirected to the employer's site
