Intuitive Surgical Careers

Regulatory Affairs Specialist

Vaud, Switzerland
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: Switzerland-Vaud
Schedule: Full-time
Requisition ID: 181883

Description

Position’s Objective & Summary:
 
The Regulatory Specialist supports the department by evaluating medical device changes, determining and executing registration strategy and ensuring compliance of marketing material.
 
Roles and Responsibilities:
 
Main activities
  • Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
  • Prepares and submits Medical Device registration dossiers for assigned geographies
  • Ensures accurate records of product submission and registration
  • Coordinates registration strategy with sales & marketing stakeholders
  • Performs regulatory review of marketing material (e.g. brochures, presentations) for compliance to assigned geographies regulations
     

Additional activities

  • Utilizes project planning skills to initiate, plan, execute, and manage regulatory projects and submissions
  • Support Quality Management system activities such as CAPA, Field Safety Corrective Actions, documentation, training, management review and internal & external audits as needed       
  • 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
  • Assists and supports other employees, teams and field personnel as necessary
  • Other regulatory tasks and projects may be assigned as necessary
Qualifications

Required Knowledge, Skills, and Experience:
  • Good knowledge of the European Medical Device Directive 93/43/EEC and ISO 13485 requirements
  • Good knowledge of medical device registration (Italy, France, Poland, …) or promotion requirements in Europe
  • 2-3 years of experience in a regulatory affairs department
  • A Bachelor’s or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
  • Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results.
  • Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
  • Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
  • Orientation for work result details, with emphasis on accuracy and completeness
  • Fluent (C1 minimum) in written and spoken English
  • General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
     
Preferred Knowledge, skills and experience
  • 2 – 5 years of experience in a medical device regulatory affairs department
  • US FDA 21 CFR 803/806/820 and EU Medical Device Regulation (2017/745/EU) basic knowledge would be a plus.
  • Knowledge of emerging market regulation (e.g. Saudi Arabia, Russia)