Intuitive Surgical Careers

Senior Regulatory and Quality Specialist LACA

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: 180311

Description

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.

Position’s Objective & Summary:


Regulatory registrations/filings, Regulatory operations support, Quality Management System implementation & coordination

Roles & Responsibilities: 


Main activities
• Plans, organizes, prepares and maintains regulatory registrations and filings in LACA that are supported by distributors
• Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
• Monitors regulatory changes in LACA indirect markets to ensure compliance to local regulations are met and partner with distributors to align
• Interprets regulatory documents and interfaces either directly with the regulatory body or indirectly through a distributor or consultant for timely approval of products /product changes
• Communicates registration strategy with sales & marketing stakeholders

Additional activities


• Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, internal & external audits, Field Safety Corrective Actions
• Ensures that company procedures, processes and documentation meet the required guidelines for maintaining compliance to the Quality Management System, ISO 13485 and other applicable regulations
• Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes
• Supports the Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements
• Assists and supports other employees, teams and field personnel as necessary
• Performs other tasks and manages projects as assigned

Qualifications

Required Knowledge, Skills, and Experience:

• A Bachelor’s or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
• 5+ years of significant experience in similar function
• Knowledge of emerging market regulation (e.g. Mexico, Panama, Brazil)
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
• Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
• Ability to be effective in complex projects with ambiguity and/or rapid change
• Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines
• Good team skills with ability to collaborate, influence and lead others
• Excellent interpersonal skills, ability to work with customers and authorities
• Orientation for detail work product, with emphasis on accuracy and completeness
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile, CRM and SAP a plus
• Spanish language (speaking, reading, writing) a plus
• Strong knowledge of Quality Management System requirements to ISO 13485 required and broad understanding of what it takes to work in a regulated environment
• Fluent in written and spoken English, ideally possessing other language skills for the LACA market



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