This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Safety Manager Complaints Handling based in the United States.
This role sits at the core of post-market patient safety, ensuring that medical device complaints involving injury or death are thoroughly assessed, accurately coded, and escalated in accordance with global regulatory standards. You will provide critical clinical judgment to determine harm severity and support regulatory reportability decisions, while acting as a key liaison between medical safety and post-market surveillance teams. The position plays a vital role in safeguarding patient outcomes by identifying risks, guiding complaint investigations, and contributing to corrective and preventive actions. You will collaborate with global, cross-functional teams to ensure consistency in clinical assessments and compliance with international requirements. This is a highly impactful role that combines clinical expertise, regulatory knowledge, and strategic influence in product safety systems. It also involves continuous improvement of surveillance processes to enhance efficiency and quality across the organization.
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