Senior Medical Device Regulatory Affairs Specialist

il y a 1 semaine


Toulouse, Occitanie, France Zimmer Biomet Temps plein
Job Description:

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;
Requirements:
  • 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;
What We Offer:
  • 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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