Remote Regulatory Affairs Specialist - EU MDR

Location: Boston, Massachusetts, United States
Salary: competitive
Job Type: Contract
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Real Staffing are partnering with a Medical Device organization based in the Boston area to secure a Regulatory Affairs Specialist to support their EU MDR project.

This is at least a 12 month contract that is very likely to extend beyond this. This will ideally be on-site but the hiring manager is very flexible when it comes to a remote working arrangement.

Key Responsibilities:

  • Review and approve documentation to support Technical Document to meet MDR requirements
  • Collaborate with stakeholders to develop and maintain project plans.
  • Create, monitor and analyze project risks and identify mitigation strategies.
  • Work with project team to identify and address critical path or road block issues.
  • Ensure project plans and deliverables are compliant with appropriate design control procedures and any other applicable regulations.
  • Participate in cross functional teams to discuss and revise documents to meet MDR requirements.

Skills & Experience Required:

  • BA/BS Degree with 5 years+ in the medical device industry
  • Experience with U.S. FDA and EU MDD & MDR medical device regulations (international regulations are a plus ie China, Brazil, Japan etc)
  • Demonstrated experience with planning, oversight, and execution of multiple projects is required; project management training & certification is a plus

If this is of interest, Apply now!

Sthree US is acting as an Employment Business in relation to this vacancy.

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