Intuitive Surgical Careers
Senior Regulatory Affairs Specialist
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 190670
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 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:
Qualifications• 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