Regulatory Affairs Specialist

il y a 1 mois


Toulouse, Occitanie, France Zimmer Biomet Temps plein
Job Description

Zimmer Biomet is a global medical technology leader with a commitment to innovation and patient mobility. As a Regulatory Affairs Senior Specialist, you will play a critical role in ensuring the approval and clearance of medical devices through regulatory submissions.

Key Responsibilities:

  • Develop and manage technical files for medical devices, including preparation of documentation for Notified Bodies and FDA.
  • Collaborate with cross-functional teams to ensure regulatory interface throughout the product realization process.
  • Develop and maintain internal operating procedures and ensure compliance with applicable regulations.
  • Provide training and guidance to entry-level associates and analysts.

Requirements:

  • Bachelor's degree in a clinical or science field, or equivalent combination of education and experience.
  • 5+ years of experience in medical device regulatory affairs, with a focus on managing technical files.
  • Strong knowledge of EU medical device regulations (MDD/MDR) and international medical device regulations.
  • Excellent computer skills, including word processing, spreadsheet, and data programs.
  • Strong interpersonal skills and attention to detail.

About Zimmer Biomet:

VIMS, acquired by Zimmer Biomet Holdings, Inc., 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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