Intuitive Surgical Careers

Manager, Regulatory Compliance - Computer System Validation

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: 182128


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:

Intuitive Surgical’s Regulatory Compliance department provides expertise in ensuring regulatory compliance companywide.

Manager, Regulatory Compliance, Computer System Validation maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable ISI Quality Modules, and requirements defined in local procedures.

Ensure ISI is compliant with all current regulatory requirements and expectations. Provide Regulatory Compliance oversight regarding process, and computer System validation activities and help maintain a validated state of control.

Roles and Responsibilities:

This position has responsibility and authority for: 

• Manage a team of direct reports.
• Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
• Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
• Provide support to external and internal audits related to computerized system validation activities.
• Manage and lead a cross functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations, and accomplishing goals throughout timelines.
• Establish and sustain ISI’s computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
• Partnering with internal and external teams; sharing information to increase the collective understanding of QA and Compliance programs.
• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
• Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external).
• Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.
• Authoring and /or revising SOPs.
• Ability to provide guidance on revising validation documents and protocols.
• Administer applicable electronic systems.
• Assist as needed in audits and inspections.
• Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.
• Contribute to projects related to CSV improvements.
• Development, execution and approval of change records.
• Development, review and approval of Quality System deviations.
• Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.

Skill/Job Requirements: 

Competency Requirements: (Competency is based on: education, training, skills and experience.) In order to adequately perform the responsibilities of this position the individual must:

• Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science or technical field
• At least 6-8 years’ experience in the Medical Device / FDA regulated industry with 3-5 years’ experience in either Quality Assurance, Quality Management, IT Compliance or equivalent
• 2-3 years of direct managerial experience.
• Excellent communication and negotiation (written, verbal, and presentation) skills, and advanced problem-solving orientation and decision making skills
• Demonstrate proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable authorities and/or industry groups
• Thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications
• Good knowledge of regulatory requirements (FDA, EMEA, ICH) Experience in international and multidisciplinary environments Operational knowledge and experience with CS applications in a GXP environment
• Experience in CSV auditing and inspections against regulatory and benchmark quality standards
• Experience in working validation of ERP (SAP) and COTS application. Working on SaaS System Validation is desirable
• Ability to evaluate risks, define and execute action plans and propose innovative solutions to solve problems
• Ability to work on multiple projects concurrently and prioritize resources
• Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization.
• Strong interpersonal and leadership skills
• Proven ability to develop, present and justify positions to all levels within the company
• Demonstrates attention to detail and organizational skills
• Results driven with a strong customer and quality focus

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.