Regulatory Affairs/Quality Assuance Specialist
Under the supervision of the SVP of Regulatory and Clinical Affairs, the RA/QA Specialist works with cross-functional teams to support documentation and Quality compliance requirements on new and existing devices, as well as writing to support US and OUS regulatory submissions. This position supports product and operational compliance related to Class-3 medical device design and manufacture, obtaining regulatory approvals, and establishing and maintaining quality control and assurance in keeping with business objectives. The Regulatory Affairs and Quality Assurance Specialist oversees or participates in external regulatory inspections and ensures the timely filing of documents, records, and reports with various regulatory agencies. The position manages quality assurance and regulatory affairs activities per the approved budget and annual operating plan.