Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

My client is an innovating and dynamic Medical Device company currently expanding their Regulatory Affairs Team.

Due to this growth my client is looking for a Senior Regulatory Affairs Specialist with a strong FDA experience to join them in Geneva area.

This position will report to the Regulatory Affairs Head.

YOUR RESPONSIBILITIES:

  • This position will be focused on the registration of Class III medical devices, in particular on US and Asian countries:

– Preparation of registration dossiers (ex : technical documentation, PMA and IDE)

– Manage the follow-up of the registration procedures and preparation of responses to Competent Authorities questions

– Assist the team in the Regulatory evaluation of US changes (Change control)

– Manage the maintenance of registration dossiers (modifications and renewals)

  • 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 distributeurs
  • Follow-up the regulatory monitoring for medical devices

YOUR PROFILE :

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area
  • 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

For more details, please contact Marine Dollat at mdollat@axepta.com

Marine Dollat mdollat@axepta.com

Specialist Pharmaceutical and Medical Device recruiter and headhunter recruiting in Switzerland and France for the provision of Pharma and Medical Device staff including Quality (GCP, GMP, GLP, GxP, Quality System, Quality Engineer, Quality manager, Quality director and VP level), Regulatory Affairs or Production's position. As specialists in the placement of candidates within the Pharmaceutical Industry, our service is thorough, professional and intelligent. In addition to our permanent and contract recruitment services, we provide proactive search campaigns, advertising campaigns and dedicated account management. If you would like to have a confidential discussion regarding your search for staff or your search for a new position please feel free to contact me directly at mdollat@axepta.com