Regulatory Affairs Manager

Regulatory Affairs Manager

United States

Now seeking an experienced Regulatory Affairs Manager with a minimum of 10 years of experience in medical devices, including 510(k) and IDE submissions, Pre-Submissions, and other FDA communications. This role ensures that our client develops a high-quality product within the guidelines of the FDA’s regulations for medical device development. This role will work across several departments including Engineering, QA, and Marketing.

Required skills and experiences:

  • BS in Biomedical Engineering or equivalent from a reputable 4-year undergraduate institution
  • 10+ years of experience with medical device regulatory affairs in a small start-up environment
  • Experience with FDA medical device regulations including 510(k) submissions, IDE (Investigative
  • Device Exemption) applications, and 21 CFR 820
  • Experience with post-market surveillance, including CAPA
  • Experience with international standards like CE marks and ISO 9000 / ISO 13485
  • Ability to understand and convey complex technical information
  • Experience with documenting and testing large technical systems
  • Team player with excellent communication skills and strong attention to detail

 

Additional desirable skills and experience include:

  • Background and work experience as an engineer in developing a medical device
  • First-hand experience with medical device software, electronics, and manufacturing
  • Experience with clinical study design and implementation
  • Project/team lead experience
  • Start-up experience
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