What are the responsibilities and job description for the Post Market Surveillance Coordinator position at A&A Search Staffing?
Essential Functions:
- Maintain Post Market Surveillance documentation in accordance with procedures and Regulatory requirements to stand on its own in the event of an audit.
- Complete and submit documentation for reportable events to Competent Authorities within required timelines, including but not limited to FDA-3500A MedWatch Reports, Manufacturing Incident Reports for EMEA Vigilance (both MDD and EU MDR), MDPR for Health Canada, etc.
- Coordinate and maintain closure of complaint records in our Post Market Surveillance system.
- Maintain the storage and retrieval of active and inactive complaint records.
- Provide support for Post Market Surveillance activities.
- Support the review and evaluation of customer communications for complaint reporting obligations.
- Communicate and correspond with customers.