Intuitive Surgical Careers

Senior Director Standards and Compliance Programs

US-CA-Sunnyvale, California
Regulatory and Quality

Job Description

Job: Regulatory and Quality
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 182525


Company Description:

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:

This business leader will be responsible for building a team focused on the analysis, project management, process definition, and implementation of standards and compliance programs including Unique Device Identification (UDI), Global Data Synchronization Network (GDSN), the EUDAMED portion of the new EU Medical Device Regulation, and other GS1 standards. This leader will be instrumental in shaping our standards adoption and integration strategy, adapting it to meet commercial and regulatory requirements in a growing number of global markets, and ensuring it is cascaded throughout the entire organization.

Job Description:

• Act as global subject matter expert across all GS1 Standards (and those that emerge) associated with UDI, UDID, GDSN, EUDAMED, etc.
• Develop a deep knowledge of global market standards in unique product identification and data synchronization. Ensure Intuitive’s adoption of standards is globally consistent and maintainable across markets.
• Develop and maintain global standards adoption timeline, and support the development of Intuitive’s prioritization and program roadmap.
• Lead program and cross functional teams to develop and release all global policy and procedure documents associated with product identification, product data creation/management, and data synchronization (i.e.GS1 and GDSN).
• Work closely with global regulatory staff to fully understand applicable standards / regulations and ensure Intuitive achieves and maintains compliance.
• Partner with appropriate master data teams to establish standardized ways of defining and maintaining product data attributes.
• Communicate standards evolution and implications to internal stakeholders.
• Provide insights and direction to key internal stakeholders including but not limited to Supply Chain, Master Data, Quality, Regulatory, Labeling, Marketing, and Product Development in the areas of UDI/GTIN/GLN management.
• Act as the thought leader on the application of GS1 standards within existing processes and new use cases
• Ensure business requirements are defined/captured in relationship to standards application and management within associated enterprise IT and master data architecture and design.

Skill/Job Requirements: 

• Bachelor’s degree in Supply Chain, Engineering, Computer Science, comparable degree, or equivalent work experience required
• Minimum of 10 years of overall business experience required
• Minimum of 10 years of experience managing, building. or leading teams required
• Minimum 4 years’ experience with UDI, GS1, or similar standards required.
• Experience developing, managing, and improving business processes required.
• Experience leading and implementing large scale programs required
• Minimum of standards application, master data management, and/or supply chain experience preferred.
• Experience speaking to executives and leading business change preferred.

Experience working in or with medical device or pharmaceutical industry preferred.

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.