Remote Regulatory Affairs Specialist - EU MDR
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.
- 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.