Senior Regulatory Specialist

Profile

Job 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

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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Company Profile
The idea of surgical robotics was little more than a curiosity until 1999, the year Intuitive Surgical introduced the da Vinci® Surgical System. Today, Intuitive Surgical is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery. Since its inception, the company has consistently provided surgeons and hospitals with the tools needed to improve clinical outcomes and to help patients return to active and productive lives. - See more at: http://www.intuitivesurgical.com/company/#sthash.g55v5yPr.dpuf