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Senior Regulatory Affairs Specialist (Genf/CH)

Senior Regulatory Affairs Specialist (Genf/CH)

Job Title: Senior Regulatory Affairs Specialist (Genf/CH)
Contract Type: Permanent
Location: Geneva, Switzerland
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: HQ00120735_1582709671
Contact Name: Michael Burgstaller
Contact Email: m.burgstaller@sciproglobal.de
Job Published: February 26, 2020 09:34

Job Description

Our Client:

Is amongst the to 3 hyaluronic acid dermal filler manufacturers worldwide.

Your Tasks:

  • Under the supervision of the Regulatory Affairs Head, your main tasks will be:
    • This position will be focused on the registration of Class III medical devices in US:
      • Preparation and writing of registration dossiers (ex : PMA and IDE
      • Manage the follow-up of the registration procedures and preparation of responses to FDA question
      • Assist the team in the Regulatory evaluation of US changes (Change control
      • Manage the maintenance of US licences (ex: annual report, supplements)
    • Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
    • Prepare and support audits conducted by Notified Bodies and Competent Authorities
    • Be the regulatory affairs representative in the varied project teams
    • Key contact and support for distributors
    • Follow-up the regulatory monitoring for medical devices

The ideal Candidate:

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international are.
  • Be familiar with US FDA regulations
  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
  • Excellent knowledge of English language
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment
  • A first experience in project management would be a plus

Application Process:

  • CV to: m.burgstaller@sciproglobal.de
  • First phone call including presentation of the company

My Contact: