Regulatory Affairs Senior Specialist H/F
Il y a 2 mois
What You Can Expect
As a Regulatory Affairs Senior Specialist m/w, you are responsible for ensuring that regulatory submissions are appropriately developed for approval and clearance of medical devices. These Regulatory submissions can include, but are not limited to, preparation of technical files for class I or IIa (EU) medical devices for example. Ensures regulatory interface throughout the product realization process and during the entire product life cycle including post-market surveillance.
How You Will Create Impact
- Sits on design review teams and provides interactive feedback and assists in the development of supporting documentation.
- Develops documents to submit to Notified Bodies and FDA
- Designs Dossiers, Technical Documentation and Technical files (as per MDD 93/42/EEC or MDR (EU) 2017/745)
- Change notifications.
- Premarket notifications (510(k))
- Develops internal documentation when formal FDA submissions are not required (LTF or Memo-to-File).
- Supports, approves, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status.
- Assists in the development and updating of internal operating procedures.
- Submits documents to support International registration submission requests.
- Develops progress reports and other misc. reports as needed.
- Participates in other RA activities as needed.
- Assists with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions.
- Responds to requests from foreign governments and/or distributors to prepare and submits documentation for marketing approval as well as provide routine regulatory information to associates and affiliates.
- Assists with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Reviews proposed product changes for impact on regulatory status of the product.
- Follows Zimmer Biomet regulatory affairs policy and procedures.
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
What Will Make You Stand Out
You hold a Bachelor's or higher degree in clinical/science field, or an equivalent combination of education and experience.
You have a proven track record of at least 5+ years of working experience in medical device regulatory affairs, more specifically in managing technical files.
What Will Make You Successful
- Strong EU medical device regulations (MDD/MDR), knowledge of US regulations an advantage
- Good knowledge of international medical device regulations
- Strong computer skills, including word processing, spreadsheet and data programs
- Strong interpersonal skills and attention to detail
- Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
- Proficient knowledge of overall business environment and the marketplace for medical devices
- Mastery of relevant regulations pertinent to medical devices, as applicable
- Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
- Fluent in French and English, both in writting and speaking
Who We Are
VIMS, recently acquired by Zimmer Biomet Holdings, Inc. specializes in developing and commercializing visualization systems for laparoscopic and arthroscopic procedures, offering fully integrated broadcasting solutions and 6K-7K ultra-high-definition resolution.
EOE/M/F/Vet/Disability
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