EU MDR Lead

Cynet Systems   •  

Somerville, NJ

Industry: Technology

  •  

8 - 10 years

Posted Today

  by    Anne Lee

Job Title: EU MDR Lead - Direct Hire / Full Time / Perm

Job Location: Somerville, NJ

Job Type: Full Time / Perm / Direct Hire + Benefits

"US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time."

Job Description:

  • Perform Gap assessments on the existing process with respect to EU MDR.
  • Document and generate a report on the assessments.
  • Use technical/compliance information to guide and documentation changes.
  • Drive timely execution of Project deliv erables through monitoring & reporting status to client management / team members.
  • Create and own Change Orders in PLM to route and release documents.
  • Educate/train p roject team on labeling changes required per EU MDR requirements.
  • Co-ordinate with client SME to identify tasks and their priority and execution sequence

Required:

  • Candidate must have a minimum of 7-9 years in medical devices sector, preferably in quality or regulatory.