Senior Medical Device Regulatory Affairs Specialist
il y a 1 semaine
We are seeking a highly experienced Senior Medical Device Regulatory Affairs Specialist to join our team at Zimmer Biomet. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with regulatory requirements for the commercialization of medical devices.
About Us:Zimmer Biomet Holdings, Inc. is a leading global medical device company that specializes in developing and commercializing visualization systems for laparoscopic and arthroscopic procedures. Our fully integrated broadcasting solutions offer 6K-7K ultra-high-definition resolution.
Responsibilities:- Ensure compliance with EU medical device regulations (MDD/MDR) and US regulations;
- Develop and manage technical files, including preparation of dossiers and technical documentation;
- Assist in the development of internal operating procedures and review proposed product changes for impact on regulatory status;
- Collaborate with cross-functional teams to ensure regulatory interface throughout the product realization process;
- Prepare and submit documents to support international registration submission requests;
- Develop progress reports and other miscellaneous reports as needed;
- Bachelor's or higher degree in clinical/science field, or an equivalent combination of education and experience;
- At least 5+ years of working experience in medical device regulatory affairs, with a proven track record of managing technical files;
- Strong knowledge of EU medical device regulations (MDD/MDR), US regulations, and international medical device regulations;
- Excellent computer skills, including word processing, spreadsheet, and data programs;
- Strong interpersonal skills and attention to detail;
- Ability to manage several competing priorities and work well under pressure;
- A competitive salary range of $120,000 - $180,000 per year, depending on experience;
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off;
- The opportunity to work with a leading global medical device company and contribute to the development and commercialization of innovative medical devices;
- A dynamic and supportive work environment with opportunities for professional growth and development;
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