Support the required event reporting and investigation of all medical device complaint-related procedures, in accordance with applicable laws and regulations.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Records and evaluates complaint submissions.
- Communicates with health care providers (HCP), HCP staff and/or patient to acquire relevant complaint information.
- Coordinates with internal departments (Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing and R&D) to incorporate vital input into medical device event reports.
- Reviews and provides feedback on complaint manufacturing investigation reports.
- Records and provides regulatory reportability decisions on complaints.
- Ensures timely processing of complaints.
- Generates and submits medical device event reports to appropriate authorities and government agencies as requested and as required by applicable laws and regulations.
- Responds to inquiries regarding medical device report submission associated with device malfunction or serious injury.
- Involved in activities to prepare for audits and inspections.
- Performs root cause investigations and is involved in CAPA (Corrective and Preventive Action) activities.
- Receives returned goods and decontaminates if necessary.
- Provides material to support post-market surveillance reports.
- Reviews and closes complaint files.
- Collects complaint case and process metrics to capture and generate trend reports.
- Coordinates with other departments to provide complaint data reports as needed.
- Participates in inter-departmental cross-functional projects.
Projects and Other Duties:
- Performs other duties as assigned.
- Prior experience as a complaint handler in the medical device industry, performing all duties described above.
- Knowledge of medical terms associated with sacral neuromodulation procedure and Medical Device Reporting regulations.
- Exceptional organizational skills and attention to detail.
- Able to perform job function with minimal supervision and work independently, taking initiative to make independent decisions, where appropriate.
- Display flexibility and a positive outlook in handling new processes, technology and general change.
- Backelor's Degree in technical, scientific, or business-related discipline preferred.
- 3 years in related work experience.