Clintel Services, Inc. Regulatory Affairs Specialist (Medical Devices) in Santa Clarita, California

Job Description

A medical device company is actively seeking a Regulatory Affairs Specialist to join their company in the Santa Clarita, CA area.

POSITION SUMMARY:

Position will be managing complex projects/products, including responsibility for the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to the evaluation and solution of product development issues.

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 environment

Company Description

Clintel Services, Inc. is a specialty search firm focusing in the placement of Clinical Research/Operations, Regulatory Affairs, Quality Assurance, Medical Affairs, Business Development, Sales, Data Management, Biostatistics, Administrative and Finance/Billing professionals. We are committed to Performance, Quality and Success. Our commitment is backed by our years of collective recruiting experience as well as our advanced search solutions.