Regulatory Standard & Regulatory Intelligence Surveillance Manager
June 29, 2018
Full Time - Experienced
Medical Device, Quality/Risk Management, Submission & Registration, Worldwide Regulatory Affairs
4 Year Degree
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
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
Internal Number: #180953
About Intuitive Surgical
Surgical robotics was little more than a medical 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.
With its corporate headquarters located in Sunnyvale, California, Intuitive Surgical serves customers throughout the United States and internationally, providing technology and procedural innovation across cardiac, urology, gynecologic, pediatric and general surgical disciplines.