Intuitive Surgical Careers
Regulatory Standard and RI Surveillance Manager
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 180953
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 Function of Position:
Serve as the regulatory manager and representative on standard management assessment and Regulatory Intelligence process related to upstream and downstream of our regulatory process management.
Utilizes understanding and knowledge of trade organizations, agencies, regulatory organizations and standard committees to assess and implement standards in the areas of software, reprocessing, risks, labeling, cyber security, etc. Responsibilities include reviewing standard, performing regulatory assessments to determine the impact of design/process changes, maintaining regulatory filings and licenses and interacting with regulatory agencies to influence and discuss regulatory standards or support, if necessary, external inspections.
Roles and Responsibilities:
This position has responsibility and authority for:
• Be the subject matter expert for the company in complying with global regulatory organization such as FDA or Europe or APAC
• Use broad experience to understand standard, regulation, guidance execution in areas such as mechanics, software, reprocessing, electrical safety, data privacy, labeling, chemical substances or PMS …
• 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 standard assessment for the above markets including 510(k)s, Non-filing justifications, Technical File updates, Canadian License Applications
• Work with other international regulatory counterparts to coordinate global regulatory assessment and support associated processes
• Manage RSB (Regulatory Standard Board) and drive the organization per objectives of the RI / RA processes
• Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
• Participate in external steering committees and represent the organization during specific steering committees or industry meetings or agencies
• Perform other duties as required
Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must:
• B.S. or higher in Biomedical Engineering, Software Engineering, Electrical Engineering or Mechanical Engineering preferred.
• Non-technical degree with equivalent complex medical device experience acceptable
• Regulatory standard experience
• Participation in active standard board will be appreciated
• 10 years relevant experience working in a medical device company
• 6 to 10 years of experience in regulatory submissions and technical documentation for a medical device company
• Experience working with cross-functional teams including engineering, manufacturing, regulatory, quality etc.
• 10 years of experience in dealing and managing agencies, third party organization and dealing with standard committees or working group in AAMI, ISO, IMDRF, trade organization, …
• In-depth understanding of FDA, CE mark and Health Canada regulations
• In-depth understanding and experience meeting FDAs requirements for cybersecurity in software and network linked products
• Ability to work with cross functional 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.
• Very organized for systemic monitoring of regulation
• Management of internal and external stake holders or trade association
• Strong influencing skills
We are an AA/EEO/Veterans/Disabled employer.