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 Officer
Under the supervision of the Regulatory Affairs Head, your main tasks will be:
- Registration of Class III medical devices in US region:
- Prepare and write registration dossiers (ex: PMA and IDE).
- Manage the follow-up of the registration procedures and prepare responses to FDA inquiries.
- Assist the team in the Regulatory evaluation of 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 inspections conducted by Competent Authorities.
- Be the regulatory affairs representative in the varied project teams.
- Key contact and support for US distributor
- Be responsible for monitoring, interpreting, and implementing new regulatory requirements for US region.
To be successful in this role, you will require the following qualifications:
- Minimum 5 years’ experience in a regulatory affairs position for medical devices, preferably in international area.
- Strategic minded, analytical and detail oriented.
- Have technical writing skills and be proficient at compiling successful submissions.
- Excellent knowledge of English language.
- Enthusiastic individual and dynamic
- Ability to work in a dynamic environment.
- Be familiar with US FDA regulations would be a plus (not required).
Profil minimum requis
- Fluent english
- 5 years’ experience in a regulatory affairs position
- Experience in Medical Devices companies
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