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.
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.
Under the supervision of the Regulatory Affairs Head, this position will be focused on the management of the team dedicated to the registration of Class III medical devices in EU & US region :
Responsibilities
- Contribute to the development of regulatory strategy in the framework of new products development in collaboration with internal departments
- Supervision of compilation of regulatory documentation during development/product registration to achieve timely submissions/approvals
- Contribute and review responses to questions raised by Competent Authorities and Notified Body to ensure appropriate, consistent and complete answers to any question
- Follow-up life-cycle as well as change control activity
- Lead the preparatory activities including briefing package for interactions with Competent Authorities or Notified Body
- Combine knowledge of scientific, regulatory and business issues to meet regulatory requirements
- Proactively ensure RA excellence (support the establishment, maintenance and optimization of Regulatory Affairs processes and procedures)
- Monitor the implementation of new regulatory requirements in EU/US region through the regulatory intelligence activity
- Define the objectives of the team and support all team members
- Ensure effective communication across the global team
Experience and skills
- Typically, 8 years regulatory affairs experience in the medical device industry
- Strong ability to use initiative, prioritize and multi-task
- Well organized and structured
- Strong analytical skills
- Strong strategic thinking and leadership ability
- Excellent knowledge of English language
- Ability to work in a dynamic environment
- Be familiar with EU/US regulations
- A first experience in management is required