Intuitive Surgical Careers

Senior Regulatory Affairs Specialist

US-CA-Sunnyvale, California
Regulatory and Quality

Job Description

Job: Regulatory and Quality
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 182170


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

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

• 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.