4 days ago on jobs.ch

Senior Regulatory Affairs Specialist

TEOXANE SA

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Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

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

Senior Regulatory Affairs Specialist

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

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 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

 

Rue de Lyon, 105 1203 GENEVE