Senior Regulatory Affairs Officer (US)

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von: Teoxane SA | localité: GenèveN: TeoxaneSA

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 (US)

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 (such as IDE, original PMA and supplements) in the context of new product and product changes in accordance with FDA requirements
  • Coordinate the responses to questions raised by FDA
  • Review of product labelling Participate in audits and inspections, ensuring compliance with FDA 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
  • 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 (21CFR part 820, MDR 2017/745) and appropriate laws, guidelines and industry standards
  • Demonstrated experience in communicating with regulatory agencies including FDA and UE regulatory agencies
  • Demonstrated experience in leading, writing and submission of complex regulatory filling (e.g. IDE, PMA, CE mark, etc-)
  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Good knowledge of relevant regulations (FDA)
  • Ability to work on several projects simultaneously, ability to prioritize
  • Fluent in English with at least a B2 level in French

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