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

      POSITION REQUIREMENTS:
      ·      
      BA/BS or MS degree in Life Sciences,
      Engineering, or health care-related discipline
      ·      
      5+ years of experience in the medical device
      industry
      ·                
      preferably in a small manufacturing/R&D
      environment
      ·                
      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
      detail
      ·      
      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 - rcarey@clintelservices.com

    • 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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