Regulatory Specialist

3 weeks ago


Pune, India Cyient Full time

Designation : Regulatory Specialist

Experience : 7+

Location : Pune

Qualifications

  • Bachelor of Science in science and/or engineering field
  • 8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)
  • Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards.
  • Experience in Orthopedics industry preferred.
  • 510(k) experience and Regulatory Affairs Certification (RAC) preferred.
  • Ability to work under limited supervision with FDA, Notified Body, Authorized Representatives, 3rd party license holders and other global regulatory agencies.
  • Ability to support and execute activities related to product development teams and cross-functional projects.
  • Ability to work well with others and manage projects.
  • Excellent written and verbal communication skills. Proficient in Microsoft Office
  • Ability to read and speak English sufficiently to read, understand, and complete all documentation.

Mandatory Skills

  • Medical Device Regulations,FDA Medical Device Regulations,Regulatory Compliance,Medical Devices,Cross-Functional Teamwork


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