Senior Regulatory Affairs Specialist H/F
il y a 3 semaines
As a Senior Regulatory Affairs Specialist at Zimmer Biomet, you will play a crucial role in ensuring that regulatory submissions are meticulously crafted for the approval and clearance of medical devices. Your responsibilities will encompass a variety of regulatory submissions, including the preparation of technical documentation for class I or IIa (EU) medical devices.
Key Responsibilities
- Participate in design review teams, providing valuable feedback and aiding in the creation of supporting documentation.
- Prepare and submit 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.
- Premarket notifications (510(k)).
- Generate internal documentation when formal FDA submissions are not necessary (LTF or Memo-to-File).
- Support and review the development of package inserts and promotional materials to ensure compliance with relevant regulations.
- Assist in the formulation and revision of internal operating procedures.
- Submit documents to facilitate International registration submission requests.
- Create progress reports and other miscellaneous reports as required.
- Engage in various Regulatory Affairs activities as needed.
- Aid in the organization, distribution, storage, tracking, and retrieval of information related to the regulatory process, including electronic submissions.
- Respond to inquiries from foreign governments and distributors regarding marketing approval documentation and provide routine regulatory information to colleagues.
- Conduct research and analysis to determine the appropriate regulatory pathway 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.
- May provide mentorship and guidance to junior associates, analysts, interns, and specialists.
To excel in this role, you should possess a Bachelor's degree or higher in a clinical or scientific field, or an equivalent combination of education and experience. A minimum of 5 years of demonstrated 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 an advantage.
- Comprehensive understanding of international medical device regulations.
- Proficient in computer applications, including word processing and spreadsheet software.
- Strong interpersonal skills and meticulous attention to detail.
- Ability to prioritize multiple tasks effectively, demonstrating versatility and adaptability to changing priorities.
- Solid understanding of the business environment and marketplace for medical devices.
- Mastery of relevant regulations applicable to medical devices.
- Ability to collaborate effectively within a team and foster relationships between Regulatory Affairs and other 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 the development and commercialization of advanced visualization systems for laparoscopic and arthroscopic procedures, providing fully integrated broadcasting solutions with ultra-high-definition resolution.
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