The reviewer will conduct independent evaluations of medical device design dossiers and technical documentation to verify compliance with CE marking requirements. They will coordinate with cross-functional teams to produce comprehensive review reports that determine the safety and effectiveness of devices for certification.
The Lead Auditor will conduct third-party audits for medical device clients to ensure compliance with ISO standards, MDSAP, and CE Marking requirements. Responsibilities include managing a client portfolio, planning assessments, conducting site visits, and completing detailed audit reports.
