Remote: Regulatory Specialist – Medical Devices (228545)

Life Sciences & Technology

Job Description:

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.

Required Skills:

  • 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

Education:

  • 4 year engineering degree, mechanical or biomedical preferred.

Remote: Regulatory Specialist – Medical Devices (228545)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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