Senior Regulatory Affairs Specialist
Vor 3 Tagen
Teoxane Laboratories, a leading manufacturer of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking a highly skilled Senior Regulatory Affairs Officer to join its team in Geneva, Switzerland.
Main Responsibilities:- Develop and implement regulatory strategies for new products and product changes, ensuring compliance with FDA requirements.
- Coordinate the preparation of regulatory submissions, including IDE, original PMA, and supplements, in accordance with FDA regulations.
- Provide regulatory guidance to internal stakeholders, ensuring accurate population of RA databases and maintenance of SOPs for the Regulatory department.
- Stay up-to-date with relevant regulations, guidelines, and industry trends, and communicate effectively with regulatory agencies, including FDA and EU regulatory agencies.
- Lead, write, and submit complex regulatory filings, such as IDE, PMA, CE mark, etc.
- Minimum 7 to 10 years of experience in the Medical device industry.
- Proficient knowledge of quality standards (ISO and relevant regulations) and laws, guidelines, and industry standards.
- Demonstrated experience in communicating with regulatory agencies and leading, writing, and submitting complex regulatory filings.
- Ability to work on multiple projects simultaneously, prioritize tasks, and maintain accurate records.
- Fluent in English.
Teoxane Laboratories was established in Geneva, Switzerland, in 2003. The company specializes in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane's strength lies in its ability to offer a global patient care, using its products to restore youthful volume to the face and treat the neck and décolleté with natural results.
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