Intuitive Surgical Careers

Senior Regulatory Specialist

Sunnyvale, California
Clinical / Regulatory


Job Description

Job: Clinical / Regulatory
Primary Location: United States-California-Santa Clara County-Sunnyvale
Schedule: Full-time

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.


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 Functions of Position:

Serve as the primary regulatory representative on Product Engineering and Manufacturing teams with a focus on software and cybersecurity. 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:
o B.S. or higher in Engineering or in a Science field
• Experience:
o 8 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science)
o 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)
o Experience with new product development projects for complex products

• Skills:
o Ability to work in a fast paced environment and handle multiple projects simultaneously
o Ability to create 510(k) submissions, memos-to-file, and technical documentation for complex new products and product changes
o Strong understanding of design controls with experience in verification and validation methods and documentation
o Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.
o Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
o Ability to digest and convey information to project teams from regulators including regulations, guidance documents and standards
o Ability to review and provide critical feedback on design documentation
o Ability to learn internal procedures and processes and implement on project teams
o Good interpersonal skills and able to work well with cross-functional teams
o 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.

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