Sr Regulatory Affairs Specialist

Lausanne Permanent

added 17/09/2021

  • 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.

Job Description

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.

Contact
Julie Ardouin
Quote job ref
JN-092021-3570498

Job summary

Specialisation
Location
Contract Type
Consultant name
Julie Ardouin
Job Reference
JN-092021-3570498

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