Remote: Senior Regulatory Affairs Specialist (231387)

Life Sciences & Technology | Regulatory Affairs
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Job Description:

Our client is looking for a Senior Regulatory Affairs Specialist for a 12+ month contract. This individual must have at least 8+ years of industry experience and 6+ years focused within EU MDR. This individual will serve as the primary regulatory representative on Product Engineering and Manufacturing teams. The main responsibilities include performing Medical Device Regulations (MDR) regulatory assessments to determine the gaps and impact on design/process/products, technical file updates, creation of Summary Technical Documentation (STED), preparing regulatory submissions, maintaining regulatory filings and licenses, design input/output documentation, identification of applicable standards and guidance documents, and interacting with regulatory agencies as needed. This professional needs to have extensive experience preparing and submitting regulatory filings for the above markets including IDEs, 510(k)s, non-filing justifications, Technical File creation/updates, Canadian License Applications.

 

Required Experience:

  • Regulatory Affairs
  • EU MDR
  • Gap Assessments
  • IDE / 510k Submissions
  • Project Management Skills
  • STED Template Creation – PLUS
  • Regulatory Intelligence exp – PLUS
  • Education: B.S. or higher in Engineering or in a science field or equivalent related experience

 

 

Remote: Senior Regulatory Affairs Specialist (231387)

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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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