Primary Location: Switzerland-Vaud-Aubonne
Requisition ID: 201093
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
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.