EU MDR Specialist in Braintree, MA at Eliassen Group

Date Posted: 10/29/2020

Job Snapshot

Job Description

This consultant will be responsible for updating technical files and design dossiers to meet the new EU MDR requirements.  They will be responsible for reviewing Tech Files and then conducting the hands on upgrades required to transition from MDD to  EU MDR compliance.

Experience with the following would be helpful:

  • Clinical Evaluation Reports (CER)
  • RAPS
  • Familiarity with ISO 13485, ISO 14971 and IEC 60601

This is a REMOTE POSITION.

No 3rd parties please.

key words: Medical Device, Regulatory, EU MDR, MDD