Regulatory Affairs & Clinical Specialist

Teoxane SA

  • Date de publication :

    22 mars 2023
  • Taux d'activité :

  • Type de contrat :

    Durée indéterminée

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Regulatory Affairs & Clinical 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:

Regulatory Affairs and Clinical Specialist

Responsibilities :

Under the supervision of the Regulatory Affairs Manager - Team Innovation, this position will consist in the following:

  • Regulatory support to Clinical development in the frame of clinical investigations for non-marketed product:
    • Work closely with the Clinical department and represent Regulatory Affairs to ensure regulatory compliance of clinical investigations
    • Coordinate the preparation of applications for conducting clinical investigations in US & EU region
    • Support the Clinical department in the preparation of the clinical documentation (Protocol, Investigator brochure, Clinical Study Report-)
  • Participate to meetings with Health Authorities /Notified Bodies
  • Support the preparation of MDR clinical documentation such as Clinical Evaluation Plan & Report (CEP/CER), Post-Market Clinical Follow-up Plan & Report (PMCF) and Periodic Safety Update Report (PSUR)
  • Support the preparation of clinical sections of regulatory dossiers (PMA, MDR technical documentation)
  • Coordinate the preparation of labelling for non-marketed product (IFU, SSED, SSCP)

Qualifications :

  • At least 4-5 years of regulatory affairs experience in the medical device industry (preferably under the Class III medical device environment).
  • Effective written and verbal communication skills
  • Attention to details
  • Ability to work in a dynamic environment
  • Be familiar with US & European medical device regulations
  • General understanding of regulations applicable to the conduct of clinical trials
  • Practical experience with clinical investigation submission in EU and/or the US