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 the regulatory submission process for medical devices. Your expertise will ensure that all submissions are meticulously prepared for the approval and clearance of products, particularly focusing on technical files for class I or IIa medical devices under EU regulations.
Key Responsibilities
- Participate in design review teams, providing constructive feedback and assisting in the creation of necessary documentation.
- Prepare comprehensive documents for submission to Notified Bodies and the FDA, including:
- Design 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).
- Support and review the development of package inserts and promotional materials to ensure compliance with relevant regulations.
- Contribute to the formulation and revision of internal operating procedures.
- Facilitate international registration submission requests.
- Compile progress reports and other miscellaneous documentation as required.
- Engage in various Regulatory Affairs activities as needed.
- Assist in the organization and management of regulatory information, including the submission process.
- Respond to inquiries from international governments and distributors regarding marketing approval documentation.
- Conduct research and analysis to determine the appropriate regulatory pathways for new or modified products.
- Evaluate proposed product changes for their regulatory implications.
- Adhere to Zimmer Biomet's regulatory affairs policies and procedures.
- Provide mentorship and guidance to junior team members and interns.
The ideal candidate will possess a Bachelor's degree or higher in a clinical or scientific discipline, or a comparable 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.
Preferred 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.
- Able to manage multiple priorities effectively, demonstrating flexibility and adaptability.
- Comprehensive understanding of the medical device business environment and marketplace.
- Expertise in relevant regulations governing medical devices.
- Ability to collaborate effectively within a team and foster relationships across 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 developing and commercializing advanced visualization systems for laparoscopic and arthroscopic procedures, providing state-of-the-art broadcasting solutions and ultra-high-definition imaging capabilities.
EOE/M/F/Vet/Disability
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