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Senior Regulatory Affairs Specialist

TEOXANE SA

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Teoxane Laboratories were founded in 2003, in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide. Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment. We have a significant global presence in over 90 countries worldwide.

 

In the frame of the growth of our business, we are looking for a:

 

Senior Regulatory Affairs Specialist

Teoxane Laboratories were founded in 2003, in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide. Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment. We have a significant global presence in over 90 countries worldwide.

 

In the frame of the growth of our business, we are looking for a:

 

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

Your profile :

  • Minimum 5 years experience in a regulatory affairs position for medical devices OR pharmaceutical, 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 and basic French 

  • 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

 

Rue de Lyon, 105 1203 GENEVE