Senior Regulatory Affairs Specialist
il y a 2 semaines
At Zimmer Biomet, we strive to push the boundaries of innovation and drive our mission forward. As a global medical technology leader, we enhance patient mobility with our products and technologies every 8 seconds. To support our talent team, we focus on development opportunities, robust employee resource groups, a flexible working environment, location-specific competitive total rewards, wellness incentives, and a culture of recognition and performance awards.
Key Responsibilities:- Ensure regulatory submissions are appropriately developed for approval and clearance of medical devices.
- Prepare technical files for class I or IIa (EU) medical devices.
- Support, approve, and participate 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.
- Submit documents to support International registration submission requests.
- Assist with assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process.
- Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval and provide routine regulatory information to associates and affiliates.
- Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
Requirements:
- Bachelor's or higher degree in clinical/science field, or an equivalent combination of education and experience.
- Proven track record of at least 5+ years of working experience in medical device regulatory affairs, more specifically in managing technical files.
- 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.
- Proficient knowledge of overall business environment and the marketplace for medical devices.
- Mastery of relevant regulations pertinent to medical devices, as applicable.
- Fluent in French and English, both in writing and speaking.
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