Medical Event Specialist
Where
- Santa Ana, CA
What you'll be doing
- Responsible for reviewing and processing all potentially reportable events and determining whether a MDR and/or vigilance report is required based on the information contained in the complaint record. Prepare and file initial and final submissions as required by regulations, including the documentation of the information reviewed and the rationale for filing/not filing a report. Work with the regional complaint handling units and conduct follow up activities in order to gather the necessary information for the initial and supplemental reports. Perform verification and quality review of reports filed by peers. Assure compliance to the AMO medical event and quality system procedures. Demonstrates thorough understanding of quality management standards as outlined in good manufacturing practices (GMPs), FDA code of federal regulations (CFRs) and ISO 13485. Actively participates in departmental process improvements to effectively communicate shared knowledge to contribute to overall success of AMO. Responsible for compliance with applicable corporate and divisional policies and procedures. Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or vigilance reportability. Case process MDRs through all steps, including closing files. Document the decision to file/not file rationale in the complaint handling system. File all medical events and reportable malfunctions within the required timeframe. Analyze medical event data to identify any trends and provide information to department management. Produces ad-hoc reports related to MDRs as needed. Participates in (and presents data as needed) monthly review for AMO product lines. Coordinate and work with the customer service team, sales representatives, field service representatives and site quality to promote accurate and complete documentation, including investigations where needed, of the compliant file. Initiate and field telephone calls and all other modes of communications with customers in order to gather all necessary information for MDR and vigilance reporting. Update the MDR database to support preparation of internal monthly reports, external annual MDR reports and risk evaluation process.
What your background should be
- Minimum of four (4) years experience working in medical complaint handling with medical devices and/or pharmaceutical products. Two (2+) years experience with medical optic products preferred. Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day). Keyboard use (greater or equal to 50% of the workday).
Required Schooling / Training
- Bachelors degree in a science, technical or related field is required.
Who is the client company
- The client company is a healthcare service provider.
- If you are interested in this position, send your resume to apply@kochdavis.com
