We are still hiring

We hope that through this challenging time, you and your family are staying safe and healthy. Though the COVID-19 pandemic is presenting unprecedented challenges, we continue to hire for our open positions. Our recruiting and hiring teams are taking prudent measures to minimize the spread of COVID-19 and still provide you with a great candidate experience. However, due to adjustments in work, life, and an increase in applications, we may start to experience some delays. Thank you for your patience and understanding.

To learn more about Intuitive’s response to COVID-19, see our company statement.

Global Distribution RA/QA Specialist

Job Description

Job: Regulatory and Quality
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 201013

Description

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 EEMEA countries 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 EEMEA 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:
  • 4+ years of significant experience in similar function
  • Strong knowledge of the EU Medical Device Directive (93/42/EEC) and Health Canada regulation
  • Knowledge of emerging market regulation (e.g. Russia, Saudi Arabia, Pakistan)
  • 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
  • A Bachelor’s or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
  • 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 European market

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.