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