- Class III Medical Devices
- Innovative start-up
About Our Client
Our client is a start-up established in Vaud for several years and developing an innovative medical devices.
Regulatory Affairs 40%
- Preparation of CE-mark Technical Documentation for transition to MDR certification
- Support submission and follow-up with the Notified Bodies
- Contribute to the IDE and PMA submission process at FDA
Regulatory activities in PMS Reporting 30%
- Conduct regulatory and investigation tasks in customer complaints' process
- Support event reporting to ECs and NCAs
- Participate to the periodic reports required by MDR
Regulatory activities in product development 30%
- Manage the translations of manuals and labels (EU and US)
- Conduct Risk Management processes
- Participate to Regulatory strategy for new products
- Represent Regulatory function on product development teams
The Successful Applicant
- Master's Degree; preferred in Biomedical Engineering or related domains.
- Minimum of 6 years of experience in a Regulatory position for pharmaceutical or medical devices, or Advanced Studies in Regulatory Affairs with a minimum of 4 years of experience.
- Experience of working under a Quality Management System for Medical device.
- Good knowledge of MDR 2017/745.
- Knowledge of US FDA 21 CFR 820, FDA Clinical Regulations is a plus.
- Fluent Written and Spoken English
- Knowledge of German is a plus
- Strong technical writing skills
What's on Offer
Great opportunity to join an agile and flexible company with responsibilities on Regulatory Affairs for Europe and US markets.