Regulatory Affairs Director EU

vor 4 Wochen


Genf, Genf, Schweiz Teoxane SA Vollzeit

About Teoxane Laboratories

Teoxane Laboratories, a company dedicated to innovation and excellence, is seeking a highly skilled Regulatory Affairs Director to lead our EU and US regulatory team. With a strong focus on strategic expertise and leadership, this role will play a crucial part in ensuring compliance with EU and US regulations for our innovative products.

Key Responsibilities

  • Develop Regulatory Roadmap: Create and implement a regulatory strategic roadmap aligned with business objectives, ensuring timely submissions and approvals for our products.
  • Regulatory Leadership: Provide strategic guidance and leadership to cross-functional teams, ensuring regulatory strategies are aligned with business objectives.
  • Regulatory Intelligence: Monitor new EU and US requirements, adapting our strategy to ensure compliance and business success.
  • Regulatory Strategy: Contribute to key strategic decisions impacting global regulatory compliance processes and procedures.
  • Regulatory Submission: Oversee the compilation of regulatory submission files, ensuring timely submissions and approvals.
  • Regulatory Excellence: Ensure RA excellence by supporting establishment, maintenance, and optimization of Regulatory Affairs processes and procedures.

Requirements and Skills

  • Deputy PRRC diploma and experience.
  • Minimum 10 years of experience in regulatory affairs.
  • Expertise in EU and US regulations, with a strong background in high-risk medical devices.
  • Strong leadership and team management skills.
  • Ability to resolve problems and make regulatory decisions.
  • Experience in negotiating with regulatory agencies and Notified Bodies.
  • Strong analytical skills and strategic thinking.
  • Ability to work in a dynamic environment.
  • Fluency in English.


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