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.

Julie Ardouin
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Job summary

Contract Type
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Julie Ardouin
Job Reference

PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.