Regulatory Affairs Specialist
il y a 1 mois
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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