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Junior Regulatory Affairs Specialist

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Junior Regulatory Affairs Specialist

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

Qualifications & Experience

  • A minimum of 2 years adequate work experience in international environment in regulatory field

MD or Pharmaceutical

  • Experience with US FDA regulations is mandatory, experience with Far East REgulation would be

a plus

  • Native or near native written and oral English and basic French
  • Strong project management skills is an asset.

If you feel the description is matching your profile and expectations, please feel free to send your CV and certificates to jeanne.navarro@okcadres.ch.

We will be happy to further discuss this opportunity with you.

Adresse

Rue Michel Roset 2 1201 Genève

Site web https://www.okjob.ch

Evaluation globale

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