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EU-MDR Lead Reporting Analyst

Acton, Massachusetts 55902

Category: Professional Job Number: 17435

 

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 tstewart@myvoca.com and reach by phone at 507-303-8177. Thanks!

 

Position Details 

Job Description:

  • 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. 


Qualifications

  • 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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Tareyl Stewart

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