Sr. Regulatory Affairs Specialist

Medical Device - Regulatory Affairs
Hays has partnered with a large, global Medical Device Manufacturer that is adding a Sr. Regulatory Affairs Specialist to their facilities in Tennessee. This opportunity is with a fantastic company recognized worldwide as a leader within Medical Device and Medical Technology.

This person will primarily be focused on preparing and reviewing technical documents, especially those pertaining to the EU. The incumbent will need to be able to communicate changes to global markets and provide submission deliverables.

Essential Functions, Duties, and Responsibilities
  • Support in the generation of Technical Files and Design Dossiers
  • Work with cross functional teams to deliver supporting documentation
  • Supports and implements the global market change program
  • Prepares for and assists with Notified Body technical audits; responds accordingly.

  • MINIMUM: 3 years Regulatory experience within the Medical Device industry.
  • Good interpersonal/communication skills are essential.
  • Experience of providing Regulatory Advice to the business is essential.
  • Ability to handle multiple demands in a fast paced environment.
  • Experience working with large and diverse groups. Strong understanding of EU Medical Device preferred.
  • Competencies: Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, proven ability to influence cross-functional teams, strong planning and analytical skills.

Apply now with an updated copy of your resume to be considered for this role.


Job type:
Full Time
Scientific and R&D
Medical Technology
Salary + Benefits
Apply Now

Talk to a consultant

Talk to Alex Alterman, the specialist consultant managing this position, located in New York City

16th Floor, 200 West 41st St

Telephone: 3473434084

Share Job