Senior Regulatory Affairs Specialist

il y a 2 semaines


Toulouse, Occitanie, France V.I.M.S Video Interventionnelle Medical Temps plein
Regulatory Affairs Senior Specialist

At Zimmer Biomet, we strive to push the boundaries of innovation and drive our mission forward. As a global medical technology leader, we enhance patient mobility with our products and technologies every 8 seconds. To support our talent team, we focus on development opportunities, robust employee resource groups, a flexible working environment, location-specific competitive total rewards, wellness incentives, and a culture of recognition and performance awards.

Key Responsibilities:
  • Ensure regulatory submissions are appropriately developed for approval and clearance of medical devices.
  • Prepare technical files for class I or IIa (EU) medical devices.
  • Support, approve, and participate in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status.
  • Submit documents to support International registration submission requests.
  • Assist with assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process.
  • Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval and provide routine regulatory information to associates and affiliates.
  • Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
  • May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.

Requirements:

  • Bachelor's or higher degree in clinical/science field, or an equivalent combination of education and experience.
  • Proven track record of at least 5+ years of working experience in medical device regulatory affairs, more specifically in managing technical files.
  • Strong EU medical device regulations (MDD/MDR), knowledge of US regulations an advantage.
  • Good knowledge of international medical device regulations.
  • Strong computer skills, including word processing, spreadsheet, and data programs.
  • Proficient knowledge of overall business environment and the marketplace for medical devices.
  • Mastery of relevant regulations pertinent to medical devices, as applicable.
  • Fluent in French and English, both in writing and speaking.


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