A Black Diamond Client is seeking a Regulatory Affairs Specialist to develop and implement regulatory strategies focused on Orthopedic products and achieve compliance with the upcoming European Medical Device Regulation. The Regulatory Affairs Specialist will provide regulatory input and strategic direction for upgrading existing MDD technical files to ensure compliance with the new requirements. Current business-critical projects include product rationalization (part number reduction), revision and upgrading of existing Design History Files and other regulatory documents, transfer of product registrations between companies, and strategic planning to ensure optimal business continuity.
- MDD (medical device directives) or MDR (medical device regulations) required.
- 2-5 years experience w/ MDD or MDR.
- Previous experience working within the Orthopedic or Spine industry
- 4 year engineering degree, mechanical or biomedical preferred.
Remote: Regulatory Specialist – Medical Devices (228545)