Regulatory Affairs Lead- European Med Device
Our client, a global medical device manufacturer in Acton, MA is looking for a Regulatory Affairs Lead to join their team to help stay compliant with European Medical Device regulations.
Serve 2 company sites as the primary point of contact in all matters of European Medical Device Regulation (EU-MDR) compliance.
Liaise with global program network in order to leverage global efforts and standardize across sites and functional units
Lead the Clinical Evaluation Reports (CER) workstream:
Coordinate with the 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 site leads.
Coordinate with Marketing & R&D staff to drive the development of an Advertising & Promotion Claims Matrix for products from the sites
Liaise with the European certifiers & Notified Bodies; ensuring continuity of EU certification for products from the 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 the company s global standards.