Intuitive Surgical Careers
Senior Regulatory Affairs Specialist
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182983
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. Responsibilities include reviewing design input/output, performing regulatory assessments to determine the impact of design/process changes, maintaining regulatory filings and licenses and interacting with regulatory agencies during inspections.
Roles and Responsibilities:
• 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 filings for the above markets including 510(k)s, Non-filling justifications, Technical File updates, Canadian License Applications
• Work with other international regulatory counterparts to coordinate global regulatory submissions/approvals
• Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
• Perform other duties as required
• B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred.
• Non-technical degree with equivalent complex medical device experience acceptable
• Minimum 8 years relevant experience working in a medical device company
• Minimum 6 years of experience in regulatory submissions and technical documentation for a medical device company
• Experience working with cross-functions teams including engineering, manufacturing, regulatory, quality etc.
• In-depth understanding of FDA, CE mark and Health Canada regulations
• Ability to work with cross function 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.
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.