SR REGULATORY AFFAIRS SPECIALIST at Badenoch and Clark

View: 128

Update day: 24-04-2024

Location: Lausanne Vaud VD

Category: Sales

Industry: Computer Software Internet Financial Services

Position: Associate

Job type: Full-time

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Job content

Our client is a Start-Up developing a Class III medical device

Aufgaben

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
Conduct regulatory and investigation tasks in customer complaints’ process
Support event reporting to ECs and NCAs
Participate to the periodic reports required by MDR
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

Qualifikation

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
Fluent in French
Knowledge of German is a plus
Strong technical writing skills

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