EU-MDR Lead Reporting Analyst

DescriptionPrimary Responsibilities: • Serve Hillrom's 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 Hillrom's 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 Hillrom's 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 Hillrom's global standards. Skill/Experience/Education• 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.