Forum Topic Regulatory Affairs
  • Conversation: Sr. Regulatory Affairs Specialist Opportunity - Medical Device - Santa Clarita, CA

    • March 21, 2017 4:12 PM GMT
    • Sr. Regulatory Affairs Specialist Opportunity - Medical Device - Santa Clarita, CA

      BA/BS or MS degree in Life Sciences,
      Engineering, or health care-related discipline
      5+ years of experience in the medical device
      preferably in a small manufacturing/R&D
      experience with medical writing, clinical
      studies, regulatory submissions, and regulatory reviews
      Must have experience developing, writing, and
      organizing all aspects of the IDE/PMA/510(k)'s and CE Submissions
      Ability to independently analyze and interpret
      novel clinical, medical and scientific data
      Current knowledge of current U.S. FDA and global
      (Canada, Australia, European Union, Latin America, India, China, etc.)
      regulatory requirements within the medical device industry.
      Excellent organizational skills and attention to
      Strong analytical, management, communication and
      interpersonal skills. Good knowledge of MS Office, Internet, databases, etc.
      Ability to work with minimal supervision in a
      busy environment
      Excellent writing skills and the ability to
      write scientific summaries
      Must be able to handle multiple assignments and
      perform in a diverse cross-functional team environmentContact me for details!Rachel Carey -

    • March 23, 2017 10:41 AM GMT
    • I have work experience about 10 years of pharmaceutical industries in QC-Microbiology.I Would like to know if I am eligible for this vacancy. Thank You

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