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Regulatory Affairs Specialist 3

Company: TalentBurst
Location: Sunnyvale
Posted on: November 11, 2019

Job Description:

Job Description

Job: Regulatory Affairs Specialist 3

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
    Skill/Job Requirements:
    • 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. Technical 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.#LI-FRESH

          Company Description:

          TalentBurst is an award winning IT, Accounting & Finance staffing firm headquartered in Boston with offices in San Francisco, Miami, Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the leading social media, technology, banks, utilities, pharmaceutical, and biotech companies.We work with 75 of the Fortune 500 companies. Our recruiting team is one of the most successful in the industry and has a strong reputation for treating our employees well and helping you find your next dream project.BenefitsAt TalentBurst, one of our founding principles has been to provide our employees with the best benefits available. Benefits we have available include:--- Health, Dental, and Vision Plan--- 401(k) Plan--- Life Insurance--- Immigration assistance--- Credit Union Membership--- Direct Deposit--- Vacation pay (only for FTEs)

Keywords: TalentBurst, Sunnyvale , Regulatory Affairs Specialist 3, Other , Sunnyvale, California

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