Head of Regulatory Affairs (EU & US regions)

Teoxane SA
Genève
4T
  • 10.07.2024
  • 100%
  • Führungsposition
  • Festanstellung

Vous retrouverez l'intégralité de nos offres d'emploi en cliquant ici : https://www.teoxane.com/.

Head of Regulatory Affairs (EU & US regions)

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. We 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:

Head of Regulatory Affairs (EU & US regions)

Under the supervision of the Regulatory Affairs Director, this position will be focused on the management of the EU & US regulatory team dedicated to Innovation & Life-cycle projects.

This position provides strategic expertise and leadership to its business partners and stakeholders (including R&D, Clinical, Quality and Marketing).

Main Responsibilities:

  • Develop the regulatory strategic roadmap according to business objectives and provide regulatory leadership for programs in the pre-market and post-market space.
  • Provide strategic mentorship to ensure alignment of regulatory strategies with business objectives and implementation of strategic plans.
  • Contribute to key strategic decisions impacting the development of global regulatory compliance processes and procedures.
  • Monitor the implementation of new EU & US requirements through the regulatory intelligence process and adapt the strategy accordingly.
  • Contribute to regulatory strategy in the framework of new products development in collaboration with cross-functional teams by defining regulatory pathways and developing regulatory strategies for submission to Notified Body and FDA.
  • Oversee the compilation of regulatory submission files for new products and product changes to achieve timely submissions/approvals (including IDE and PMAs).
  • Contribute and review responses to questions raised by the Notified Body and FDA to ensure appropriate, consistent and complete answers to any question.
  • Support life-cycle management activities (including change control regulatory impact assessment for EU & US regions).
  • Ensure product compliance with EU & US regulations and standards.
  • Lead the preparatory activities including briefing package for interactions with FDA.
  • Ensure RA excellence by supporting establishment, maintenance and optimization of Regulatory Affairs processes and procedures in order to ensure the continuous improvement of Quality Management System (QMS).
  • Ensure effective communication across the global Regulatory Affairs team.
  • Mentor, train, supervise Regulatory Affairs Team dedicated to EU & US regions empowering them to interact and negotiate with regulators.

Requirements and skills

  • You have the diploma and experience to act as Deputy PRRC.
  • Minimum 10 years of experience.
  • We are looking for an expert of regulatory affairs professional with a significant experience in the medical device field (high-risk medical devices) with an extensive knowledge of EU & US regulations and strong leader with at least one Team management experience.
  • Strong ability to take ownership and responsibility for actions.
  • Ability to resolve problems and make regulatory decisions.
  • Experience in negotiating with regulatory agencies and Notified Body.
  • Demonstrate skills handling multiple projects simultaneously.
  • Strong analytical skills.
  • Strategic thinking and leadership ability.
  • Ability to work in a dynamic environment.
  • Fluency in English and French.