Clinical / Regulatory
United States-California-Santa Clara County-Sunnyvale
Manager, Regulatory Submissions
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
Work closely with Regulatory Affairs Submissions senior management to develop, manage and implement regulatory strategy for new products, new indications, and major changes to existing products in the US, EU, and Canada. Provide guidance to staff supporting project team activities, preparing submissions, and interfacing with regulatory authorities during submissions reviews, assure timely regulatory filings, assure that US submissions are accepted for review the first time, and assure that all submissions documentation (i.e., submissions content and complete communications records) are properly archived. Work closely with the Sr. Director, Regulatory Affairs to staff, develop, and manage the submissions team.
Roles and Responsibilities
Playing a key role in the development of the company's regulatory strategy for existing new product lines/indications (US, CE mark and Canada).
Providing regulatory support and guidance to project teams working on new products/indications or major changes to products.
Overseeing submissions related to new products/indications, Non-Filing Justifications, Technical Files for EU, and Canadian License Applications so that regulatory clearances and approvals are secured in a timely manner; assuring that specific information needed to facilitate the regulatory clearance processes for the rest of the world is documented in the US and EU submissions.
Establishing, reviewing, and approving "Non-Filing Justifications" for product development projects and product changes.
Compiling Technical Files for Europe and securing CE Mark from the Notified Body.
Providing oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance), where appropriate.
Supporting continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process.
Staffing, developing, and managing the Regulatory Submissions team.
Core Competencies, Skills and Experience Requirements
Experience in creating 510(k)s, pre-submissions, IDEs, Non-Filing Justifications, and Technical Files for new products.
Experience in new product introduction.
Experience in verification and validation methods and documentation.
Experience with third-party testing such as UL/ IEC product testing, biocompatibility testing, sterilization.
Excellent ability to work in cross-functional environments.
Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
Good interpersonal skills and able to work well with cross-functional teams.
Good project management skills.
Experience working directly with the FDA and Notified Bodies.
Strong personnel management skills.
Education and Training Requirements
B.S. or higher in sciences. Biomedical Engineering, Electrical Engineering or Mechanical Engineering a plus.
Minimum 6 years relevant regulatory experience with 5+ years of experience in submissions and technical documentation for a medical device company.
Minimum 3 years experience managing a regulatory group responsible for new product submissions for US, EU, and Canada
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