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Regulatory Affairs Specialist - Switzerland - Aubonne (9 months contract)

Job Description

Job: Regulatory and Quality
Primary Location: Switzerland-Vaud-Aubonne
Schedule: Full-time
Requisition ID: 201093

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.

 

Primary Function of Position:

The Regulatory Affairs Specialist supports the department by converting/creating medical device technical documentation according to the EU Medical Device Regulation.

 

Roles and Responsibilities:

  • Prepares and submits Medical Device registration dossiers for European markets according to EU MDR requirements
  • Ensures accurate records of product submission and registration
  • Coordinates registration strategy with sales & marketing stakeholders
Qualifications

Required Knowledge, Skills, and Experience:

  • Good knowledge of the EU Medical Device Regulation (EU) 2017/745 and European Medical Device Directive 93/42/EEC
  • 3-5 years of experience in a medical device 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.
  • 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:

  • US FDA 21 CFR 803/806/820 and STED (Summary of Technical Documentation) knowledge would be a plus.