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:
Regulatory Affairs Officer (US)
Main activities:
- Provide Regulatory strategies for FDA submissions as RA representative in cross-functional teams:
-
- Work and interact closely with FDA reviewers.
- Work closely with R&D, Clinical and Medical teams to coordinate the preparation of FDA applications and responses to FDA questions.
- Represent Regulatory SME in Design Control documentation review.
- Actively coordinate the preparation of regulatory submissions (such as IDE, original PMA and supplements, Qsub's) in the context of new product and product changes in accordance with FDA requirements.
- Become the US Agent for Teoxane products in the USA.
- Provide regulatory impact assessment on proposed product and process changes according to FDA requirements.
- Review of product labelling.
- Review of marketing material according to FDA regulation.
- Participate in audits and inspections, ensuring compliance with FDA requirements.
- Stay up-to-date with relevant regulations, guidelines, and industry trends, and provide gap and impact assessments on new/updated FDA regulations and provide strategic regulatory guidance to internal stakeholders.
- Ensure accurate population of RA databases.
- Ensure accurate maintenance of the US Regulatory archives and documentation.
- Ensure the proper and prompt update of regulatory SOP's.
Your profile:
- Minimum 7 years of experience in regulatory affairs in medical device industry.
- Proficient knowledge of quality standard (MDSAP / ISO 13485 / GUDID), relevant FDA regulations (21CFR part 4, 7, 800, 807, 812, 814, 820, 830, 860, Federal Food, Drug, and Cosmetic Act, Blue book memo, PIBs, etc.) and appropriate laws, guidelines and industry standards.
- Demonstrated experience in communicating with regulatory agencies, specifically with FDA.
- Successful track of records to demonstrate significant experience in leading, writing and getting approval on PMA submissions for class III medical devices incorporating medicinal substances (e.g. IDE, PMA, Panel track supplement PMA, etc-).
- Good knowledge of relevant regulations (FDA).
- Good written and oral communication and technical writing skills.
- Regulatory and technical detail oriented.
- Ability to work on several projects simultaneously, ability to prioritize.
- Proficient in English; French is nice to have.
- Available to travel to Geneva periodically (20% of the time / one week per month).
