REGULATORY AFFAIRS SPECIALIST 3

Sunnyvale, CA 94086

Posted: 11/07/2019 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 7115

Job Description


Our client manufactures and markets robotic products designed to improve clinical outcomes of patients.

 

Primary Function of Position:

Serve as the primary regulatory representative on Product Engineering and Manufacturing teams. Responsibilities include reviewing design input/output, performing regulatory assessments to determine the impact of design/process changes, maintaining regulatory filings and licenses and interacting with regulatory agencies during inspections.

 

Roles and Responsibilities:
  • Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation.
  • Assess the impact of the product/process changes and determine regulatory pathway for US, EU and Canadian markets.
  • Prepare and submit regulatory filings for the above markets including 510(k)s, Non-filling justifications, Technical File updates, Canadian License Applications
  • Work with other international regulatory counterparts to coordinate global regulatory submissions/approvals
  • Provide oversight of third-party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
  • Perform other duties as required

 

Job Requirements

Skills:

  • In-depth understanding of FDA, CE mark and Health Canada regulations
  • Ability to work with cross function project teams and understand complex products
  • Ability to work in a fast-paced environment and handle multiple projects simultaneously
  • Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
  • Ability to review and provide critical feedback on design documentation
  • Able to learn internal procedures and processes and implement the same on project teams.
  • Good interpersonal skills and project management skills.

 

Education:

  • B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred.
  • Non-technical degree with equivalent complex medical device experience acceptable

 

Experience:

  • 8 years relevant experience working in a medical device company
  • 6 years of experience in regulatory submissions and technical documentation for a medical device company
  • Experience working with cross-functions teams including engineering, manufacturing, regulatory, quality etc.
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