3 days old

Sr. Regulatory Affairs Engineer/Specialist

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
    193435

Job: Regulatory and Quality
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 193435

Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

Serve as the primary regulatory representative on Product Engineering and Manufacturing teams with a focus on software and electromechanical systems. Responsibilities include reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting with regulatory agencies.

Roles and Responsibilities:


  • Support product development teams on regulatory issues, including review of 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-filing justifications, Technical File creation/updates, Canadian License Applications.

  • Identify and convey requirements from applicable standards and guidance documents to project teams

  • Be the subject matter expert for the company in complying with FDA guidance documents regarding cybersecurity

  • Provide leadership on documentation issues and mentor teams on requirements

  • Continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process

  • Work directly with regulatory agencies on regulatory issues and submissions

  • Support international regulatory efforts as needed

  • Perform other duties as required

    Qualifications

    Skill/Job Requirements:

    Education
    : B.S. or higher in Engineering or in a Science field

    Experience:

  • 8 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science)

  • 6 years of experience in submissions and technical documentation for medical devices (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science plus 3 years)

  • Experience with new product development projects for complex products

  • Experience with software controlled and standalone software medical devices including cybersecurity.

    Skills:

  • Ability to work in a fast paced environment and handle multiple projects simultaneously

  • Ability to create 510(k) submissions, memos-to-file, and technical documentation for complex new products and product changes

  • Strong understanding of design controls with experience in verification and validation methods and documentation

  • Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.

  • Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions

  • Ability to digest and convey information to project teams from regulators including regulations, guidance documents and standards

  • Ability to review and provide critical feedback on design documentation

  • Ability to learn internal procedures and processes and implement on project teams

  • Good interpersonal skills and able to work well with cross-functional teams

  • Good project management skills

    We are an AA/EEO/Veterans/Disabled employer.

    We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.







  • Posted: 2019-10-10 Expires: 2019-11-08
    Sponsored by:
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    Sponsored by:
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    Sr. Regulatory Affairs Engineer/Specialist

    Intuitive Surgical, Inc.
    Sunnyvale, CA 94086

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