EU-MDR Lead Reporting Analyst
100 Discovery Way Acton, Massachusetts 55902
Voca has an immediate opening available for a EU-MDR Lead Reporting Analyst in Acton, MA! If you are interested, please forward your resume to Tareyl Stewart at email@example.com and reach by phone at 507-303-8177. Thanks!
- Serve Acton (MA) and Caledonia (MI) sites as the primary point of contact in all matters of European Medical Device Regulation (EU-MDR) compliance.
- Liaise with our global EU-MDR program network in order to leverage global efforts and standardize across sites and functional units
Lead the Clinical Evaluation Reports (CER) workstream:
- Coordinate with our global CER contractor in the development of CERs
- Cooperate with other EU-MDR workstreams in preparing inputs to CERs (e.g. Technical Files, Post-Market Surveillance).
- Plan, lead & monitor workstream; regularly report progress to EU-MDR Acton & Caledonia site leads.
- Coordinate with Marketing & R&D staff to drive the development of an Advertising & Promotion Claims Matrix for products from the Acton & Caledonia sites
- Liaise with the European certifiers & Notified Bodies; ensuring continuity of EU certification for products from the Acton & Caledonia sites.
- Review remediated EU-MDR Technical Documentation, Post-Market Surveillance, Labeling & IFUs, CER (& other) deliverables & provide advice, ensuring they are developed compliant to EU-MDR requirements and consistent with our global standards.
- At least 5 years experience in applying European Medical Device regulations; 10 years preferred.
- Bachelor degree (or equivalent) in Science or Engineering required; post-graduate degree (or equivalent) preferred.
- Highly competent in written & spoken English.
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