Regulatory Affairs Specialist

 — GENEVE
22.11. | Employé | 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

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 other countries:
  1. Preparation of registration dossiers
  2. Manage the follow-up of the registration procedures, prepare and manage timely submissions of responses to questions from these Competent Authorities
  3. Assist the team in the Regulatory evaluation of US changes (Change control)
  4. 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 or 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

 

To be successful in this role, you will require the following qualifications:

  • Minimum 2/3 years of Regulatory Affairs experience in medical devices or pharmaceuticals, preferably in international area
  • Be familiar with submissions to international regulatory authorities. Preference in US and EU
  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
  • Good communication skills in English (verbal, reading and writing)
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment and in interdisciplinary teams
  • A first experience in project management would be a plus

 

 

Info

22.11.2020
Employé, 100%

Profil minimum requis

  • Experience in medical devices or pharmaceuticals

Contact

TEOXANE SA

Rue de Lyon, 105

1203 GENEVE


TEOXANE SA

Rue de Lyon, 105GENEVE

Secteur

Biotechnologie / Chimie / Pharmaceutique

Année de création

2003

Avantages (6)

Fruits
Nous participons aux repas
Nous participons aux différents frais de transport

TEOXANE SA

Rue de Lyon, 105GENEVE

Secteur

Biotechnologie / Chimie / Pharmaceutique

Année de création

2003

Avantages (6)

Fruits
Nous participons aux repas
Nous participons aux différents frais de transport
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