Regulatory Affairs Manager
vor 2 Wochen
Date:22 avr. 2023
Lieu:
Genève, Corporate, 1203
Entreprise:
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 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 Manager - Team Innovation
Responsibilities:
Under the supervision of the Regulatory Affairs Director, this position will be focused on the management of the regulatory team dedicated to Innovation projects:
- Regulatory support to Clinical development:
- Work closely with the Clinical department and represent Regulatory Affairs to ensure regulatory compliance of clinical investigations
- Support the global RA Team in the preparation of responses to inquiries raised by Health Authorities/Notify Body pertaining to the clinical evidence and/or clinical claims
- Regulatory support to new product development:
- Demonstrate leadership on product development by identifying and interpreting relevant regulatory requirements and providing regulatory guidance throughout the product development cycle prior to regulatory submissions
- Work closely with the R&D department and represent Regulatory Affairs in the Design Control documentation review to ensure regulatory submission soundness
- Coordinate the preparation of the registration dossiers (US PMA, EU Technical Documentation) for initial registration of new products in accordance with FDA & EU MDR requirements
- Coordinate the preparation and participate to meetings with Health Authorities /Notified Bodies prior to regulatory submissions
- Monitor actively the Regulatory Intelligence process by ensuring evaluation of new regulations and guidelines and leading their implementation
- Ensure RA excellence (support the establishment, maintenance and optimization of Regulatory Affairs processes and procedures)
- Ensure effective communication across the global Regulatory Affairs team
Requirements and skills:
- Typically, 8 years of regulatory affairs experience in the medical device industry (preferably under the Class III medical device environment)
- Be familiar with US & European medical device regulations
- General understanding of regulations applicable to the conduct of clinical trials
- General understanding of product development process and design control
- Effective written and verbal communication skills
- Strong scientific and analytical evaluation skills
- Attention to details
- Ability to work in a dynamic environment
- Experience in people management
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.
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