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Senior Regulatory Affairs Specialist H/F
Il y a 2 mois
As a Senior Regulatory Affairs Specialist at Zimmer Biomet, you will play a crucial role in the development and submission of regulatory documentation necessary for the approval and clearance of medical devices. Your expertise will ensure compliance throughout the product realization process and the entire product life cycle, including post-market surveillance.
Key Responsibilities
- Collaborate with design review teams, providing insightful feedback and aiding in the creation of essential documentation.
- Prepare and submit comprehensive documents to Notified Bodies and the FDA, including:
- Dossiers, Technical Documentation, and Technical Files in accordance with MDD 93/42/EEC or MDR (EU) 2017/745.
- Change notifications and Premarket notifications (510(k)).
- Generate internal documentation for instances where formal FDA submissions are not mandated (LTF or Memo-to-File).
- Evaluate and approve promotional materials and package inserts to ensure regulatory compliance.
- Contribute to the development and refinement of internal operating procedures.
- Facilitate international registration submission requests by preparing necessary documents.
- Compile progress reports and other miscellaneous reports as required.
- Engage in various Regulatory Affairs activities as needed.
- Manage the assembly, distribution, storage, tracking, and retrieval of regulatory information, including electronic submissions.
- Respond to inquiries from international governments and distributors, preparing documentation for marketing approvals.
- Conduct research and analysis to identify appropriate regulatory pathways for new or modified products.
- Assess proposed product changes for their impact on regulatory status.
- Adhere to Zimmer Biomet's regulatory affairs policies and procedures.
- Provide mentorship and guidance to junior associates, analysts, interns, and specialists as necessary.
The ideal candidate will possess a Bachelor's degree or higher in a clinical or scientific discipline, or an equivalent combination of education and experience. A minimum of 5 years of experience in medical device regulatory affairs, particularly in managing technical files, is essential.
Essential Skills
- In-depth knowledge of EU medical device regulations (MDD/MDR), with familiarity with US regulations being advantageous.
- Strong understanding of international medical device regulations.
- Proficient in computer applications, including word processing and spreadsheet software.
- Excellent interpersonal skills and meticulous attention to detail.
- Ability to juggle multiple priorities effectively, demonstrating versatility and adaptability.
- Comprehensive understanding of the medical device business environment and marketplace.
- Mastery of relevant regulations applicable to medical devices.
- Ability to collaborate effectively within a team and foster relationships across various departments.
- Fluency in both French and English, with strong written and verbal communication skills.
Zimmer Biomet, through its recent acquisition of VIMS, is dedicated to advancing the field of medical technology, specializing in the development and commercialization of innovative visualization systems for laparoscopic and arthroscopic procedures, offering cutting-edge broadcasting solutions and ultra-high-definition resolution.
