Regulatory Affairs Specialist

 — Genève
25.02. | Employee | 100%

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:

 

Regulatory Affairs Specialist

Responsibilities:

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 EU:
  1. Preparation and writing of Technical Documentation according to MDR
  2. Manage the follow-up of the registration procedures and preparation of responses to the Notified Body
  3. Assist the team in the Regulatory evaluation of changes (Change control)
  4. Manage the maintenance of certificates
  • 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 Body
  • Be the regulatory affairs representative in the varied project teams
  • Key contact and support for distributors
  • Follow-up the regulatory watch for medical devices in EU

 

Qualifications and Job Specifications:

  • Minimum 3/5 years’ experience in a regulatory affairs position for medical devices
  • Be familiar with EU regulation
  • Good knowledge of collaboration with notified bodies and health authorities
  • Excellent English skills
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment.