Regulatory Affairs Senior Specialist

il y a 4 jours


Toulouse, Occitanie, France Zimmer Biomet Temps plein
Job Summary

Zimmer Biomet is seeking a highly skilled Regulatory Affairs Senior Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the development and submission of regulatory documents for medical devices.

Key Responsibilities
  • Regulatory Document Development: Develop and submit regulatory documents, including technical files, design dossiers, and technical documentation, to regulatory authorities.
  • Regulatory Interface: Ensure regulatory interface throughout the product realization process and during the entire product life cycle, including post-market surveillance.
  • Document Review and Approval: Review and approve internal documentation, including package inserts, evaluation of promotion and advertising material, and reviews of proposed product changes.
  • Procedure Development: Assist in the development and updating of internal operating procedures.
  • International Registration: Submit documents to support international registration submission requests.
  • Reporting and Communication: Develop progress reports and other miscellaneous reports as needed, and participate in other RA activities as required.
Requirements
  • Education: Bachelor's or higher degree in a clinical or science field, or an equivalent combination of education and experience.
  • Experience: Proven track record of at least 5+ years of working experience in medical device regulatory affairs, with a focus on managing technical files.
  • Skills: Strong knowledge of EU medical device regulations (MDD/MDR), international medical device regulations, and computer skills, including word processing, spreadsheet, and data programs.
  • Language: Fluent in French and English, both in writing and speaking.
About Zimmer Biomet

Zimmer Biomet is a leading medical technology company that specializes in developing and commercializing visualization systems for laparoscopic and arthroscopic procedures. We offer fully integrated broadcasting solutions and 6K-7K ultra-high-definition resolution.



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