Intuitive Surgical Careers

Senior Regulatory & Quality Specialist- Indirect markets

Switzerland-Aubonne, Switzerland
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: Switzerland-Vaud-Switzerland-Aubonne
Schedule: Full-time
Requisition ID: 183503

Description

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 EMEA countries and Canada 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 EMEA and Canada 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:

 

·        7+ 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