Senior Regulatory Affairs Specialist H/F
il y a 3 semaines
About Zimmer Biomet
Zimmer Biomet is a pioneering force in the medical technology sector, dedicated to enhancing patient mobility through innovative solutions. With nearly a century of experience, our products positively impact lives every eight seconds.
Our Commitment
As part of the Zimmer Biomet family, you will contribute to our mission of delivering mobility and improved quality of life to individuals globally. We prioritize employee development, offer a flexible work environment, and maintain a culture that values recognition and performance. Our aim is to foster an inclusive atmosphere where every team member feels valued and empowered.
Key Responsibilities
- Engage in design review teams, providing constructive feedback and aiding in the creation of necessary documentation.
- Prepare and submit regulatory documents to Notified Bodies and the FDA, including Technical Documentation and Design Dossiers in compliance with MDD 93/42/EEC or MDR (EU) 2017/745.
- Generate internal documentation for instances where formal FDA submissions are not mandated.
- Evaluate promotional materials and package inserts for regulatory compliance, and assess proposed product modifications for their regulatory implications.
- Contribute to the development and revision of internal operational procedures.
- Facilitate international registration submission requests by preparing relevant documents.
- Compile progress reports and additional documentation as required.
- Participate in various Regulatory Affairs activities as needed.
- Assist in the organization and management of regulatory submission information, including electronic submissions.
- Respond to inquiries from international governments and distributors regarding marketing approval documentation and provide regulatory information to colleagues.
- Conduct research and analysis to determine the appropriate regulatory pathways for new or modified products.
- Review product changes to assess their impact on regulatory status.
- Adhere to Zimmer Biomet's regulatory policies and procedures.
- Provide mentorship and guidance to junior associates and interns as necessary.
Qualifications
To excel in this role, candidates should 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.
Desired Skills
- In-depth knowledge of EU medical device regulations (MDD/MDR), with familiarity with US regulations considered advantageous.
- Comprehensive 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 with adaptability and flexibility.
- Strong understanding of the medical device business landscape.
- Expertise in relevant medical device regulations.
- 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.
About VIMS
VIMS, now part of Zimmer Biomet Holdings, Inc., specializes in the development and commercialization of advanced visualization systems for laparoscopic and arthroscopic procedures, providing integrated broadcasting solutions with ultra-high-definition resolution.
EOE/M/F/Vet/Disability
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