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Senior Regulatory Affairs Specialist
Il y a 2 mois
About Zimmer Biomet
Zimmer Biomet is a leader in the medical technology sector, dedicated to enhancing patient mobility through innovative solutions. With nearly a century of experience, we are committed to improving lives globally.
Your Role
As a Senior Regulatory Affairs Specialist, you will play a crucial role in the regulatory submission process for medical devices. Your responsibilities will include:
- Collaborating with design review teams to provide valuable feedback and assist in the creation of essential documentation.
- Preparing and submitting technical documentation to Notified Bodies and the FDA, including Design Dossiers and Technical Files, in compliance with relevant regulations.
- Creating internal documents when formal FDA submissions are not necessary.
- Reviewing promotional materials and product changes to ensure compliance with applicable regulations.
- Assisting in the development and revision of internal operating procedures.
- Supporting international registration submission requests.
- Generating progress reports and other necessary documentation.
- Participating in various Regulatory Affairs activities as required.
- Managing the assembly, distribution, and tracking of regulatory information and submissions.
- Responding to inquiries from international partners regarding marketing approvals and regulatory information.
- Conducting research and analysis to determine the appropriate regulatory pathways for new or modified products.
- Evaluating product changes for their impact on regulatory status.
- Adhering to Zimmer Biomet's regulatory policies and procedures.
- Providing guidance and training to junior team members as needed.
Qualifications
The ideal candidate will possess:
- A Bachelor's degree or higher in a clinical or scientific field, or equivalent experience.
- A minimum of 5 years of experience in medical device regulatory affairs, particularly in managing technical files.
Key Skills
- In-depth knowledge of EU medical device regulations (MDD/MDR) and familiarity with US regulations.
- Strong understanding of international medical device regulations.
- Proficient computer skills, including experience with word processing and data management software.
- Excellent interpersonal skills and meticulous attention to detail.
- The ability to prioritize multiple tasks and adapt to changing circumstances.
- A comprehensive understanding of the medical device marketplace.
- Expertise in relevant regulations applicable to medical devices.
- The ability to collaborate effectively within a team and build relationships across departments.
- Fluency in both French and English, with strong written and verbal communication skills.
Who We Are
Zimmer Biomet, through its recent acquisition of VIMS, specializes in cutting-edge visualization systems for laparoscopic and arthroscopic procedures, delivering integrated broadcasting solutions with ultra-high-definition resolution.
We are an equal opportunity employer.
