Senior Regulatory Affairs Officer (UE)

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. 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:

Senior Regulatory Affairs Officer
 

Main activities

• Provide Regulatory strategies for projects as RA representative in cross-functional teams
• Responsible for regulatory Assessment on product changes 
• Coordinate the preparation of regulatory submissions in the context of new product and product changes in accordance with EU requirements
• Coordinate the responses to questions raised by the Notified Body
• Review of UE product labelling
• Participate in audits and inspections, ensuring compliance with UE requirements
• Stay up-to-date with relevant regulations, guidelines, and industry trends, and provide strategic regulatory guidance to internal stakeholders
• Ensure accurate population of RA databases
• Maintain and update SOP’s for Regulatory department
• Key contact and support for UE distributors
• Any other specific assignment that may be entrusted to you by the Management

Your profile

• Minimum 7 to 10 years of experience in Medical device industry
• Proficient knowledge of quality standard (ISO 13485) and relevant regulations (MDR 2017/745) and appropriate laws, guidelines and industry standards
• Demonstrated experience in communicating with regulatory agencies and Notified Body
• Demonstrated ability in analytical reasoning and critical thinking skills
• Ability to work on several projects simultaneously, ability to prioritize
• Excellent planning and organizational skills
• Fluent in English with at least a B2 level in French

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TEOXANE promotes equal opportunity and places at the heart of its human resources management policy the fight against all forms of discrimination based on age, gender, origin, disability, or any other personal characteristic.