Regulatory Affairs Senior Specialist
il y a 3 semaines
We are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team at Zimmer Biomet. As a key member of our regulatory affairs team, you will be responsible for ensuring that our medical devices meet the highest regulatory standards.
Key Responsibilities- Develop and maintain technical files for medical devices, including preparation of documentation for Notified Bodies and FDA.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product realization process.
- Develop and implement internal operating procedures to ensure regulatory compliance.
- Provide training and guidance to entry-level associates, analysts, interns, and specialists on regulatory affairs policies and procedures.
- Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Review proposed product changes for impact on regulatory status of the product.
- 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 knowledge of EU medical device regulations (MDD/MDR) and US regulations.
- Good knowledge of international medical device regulations.
- Strong computer skills, including word processing, spreadsheet, and data programs.
- Strong interpersonal skills and attention to detail.
- Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities.
- Fluent in French and English, both in writing and speaking.
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.
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.
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