Regulatory Affairs Officer

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

Main responsibilities :

As a Regulatory Affairs Officer, you will support the department in regulatory activities for the registration of Medical Devices of Class III in Europe. Your main tasks will be related to the transition to the new European regulation.

Ensure the CE certification of the products according to the MDR 2017/745 requirements :

• Prepare and write the Technical Documentation of the products according to MDR 2017/745 requirements
• Ensure the follow-up of the registration and/or renewal procedures of the products in Europe
• Prepare and write the responses to the Notified Body’s questions
• Ensure maintenance of CE certificates
• Ensure regulatory compliance of the packaging elements

Be the Regulatory Affairs representative within development projects :

• Define the applicable regulatory requirements for the registration of new products in Europe
• Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
• Advise project team members on regulatory requirements

Support the Regulatory Affairs team in the following routine missions :

• Carry out the regulatory impact assessment of the changes on products/processes (change control)
• Prepare and support audits conducted by the Notified Body
• Be the key contact for European distributors
• Carry out the regulatory watch of medical devices in Europe

Your profile :

• Minimum 3/5 years’ experience in a regulatory affairs position for medical devices
• Familiar with EU regulation (MDR 2017/745, MDD 93/42/EEC)
• Good knowledge of collaboration with Notified Bodies and Health Authorities
• Versatile, proactive, and dynamic, you demonstrate great rigor and autonomy in your work
• You demonstrate good interpersonal skills, and team-oriented personality allowing you to work within cross department teams
• Ability to work in a dynamic environment
• A good level of spoken and written English is required