Medical Device Reporting Supervisor

Job Summary:

A leading healthcare technology organization is seeking a Supervisor, Medical Device Reporting Remediation to lead a high-volume team supporting retrospective Medical Device Reporting activities. This role is responsible for ensuring compliant, timely, and audit-ready MDR assessments, investigations, submissions, and remediation activities while maintaining alignment with regulatory requirements. The ideal candidate will bring strong leadership experience, deep MDR knowledge, and the ability to drive operational excellence in a fast-paced regulatory environment.

Key Responsibilities:

• Lead and manage a team supporting retrospective Medical Device Reporting remediation activities

• Oversee reportability assessments, investigations, data collection, MDR preparation, and regulatory submissions

• Ensure compliance with applicable MDR regulations, internal procedures, and reporting requirements

• Establish team priorities and monitor productivity, quality, and remediation timelines

• Provide coaching, mentorship, and performance feedback to team members

• Serve as the escalation point for complex regulatory and complaint handling cases

• Drive process improvements, workflow standardization, and operational efficiency initiatives

• Support corrective and preventive action activities and maintain audit readiness

• Collaborate with Regulatory Affairs, Quality, Clinical, and cross-functional stakeholders

• Track key performance metrics and ensure timely completion of remediation deliverables

Required Qualifications:

• Bachelor’s degree in Science, Engineering, Healthcare, or a related field

• Minimum of 5 years of experience in medical device complaint handling, MDR reporting, or regulatory compliance

• Minimum of 2 years of direct people management experience

• Strong knowledge of Medical Device Reporting regulations and regulatory compliance requirements

• Experience with complaint handling systems such as ETQ Reliance, TrackWise, or similar platforms

• Experience supporting regulatory inspections and CAPA activities

• Strong leadership, performance management, and process improvement skills

• Ability to manage high-volume workflows and multiple competing priorities

Preferred Qualifications:

• Experience leading MDR remediation or retrospective review programs

• Familiarity with electronic MDR submission processes

• Experience with device, patient, and evaluation coding activities

• Knowledge of risk management methodologies and CAPA integration

• Experience developing or optimizing remediation workflows

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $38.50/hr – $40.00/hr