Regulatory Affairs Senior Specialist H/F

il y a 1 semaine

Toulouse, France Zimmer Biomet Temps plein
Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet

What You Can Expect

As a Regulatory Affairs Senior Specialist m/w, you have an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.

How You Will Create Impact

  • 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 submit 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.
  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
  • Evaluates risk of proposed regulatory strategies and offers solutions.
  • Reviews proposed labeling for compliance with applicable US and international regulations.
  • Writes, manages, and approves the development of package inserts.
  • Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations.
  • Reviews proposed product changes for impact on regulatory status of the product.
  • Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.
  • Follows Zimmer Biomet regulatory affairs policy and procedures.
  • May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
  • Communicates with regulatory and governmental agencies.

What Will Make You Stand Out

You hold a Bachelor's degree in Technical, Life Sciences, Engineering or related field, or an equivalent combination of education and experience.

You have a proven track record of at least 5+ years of working experience in a similar position, ideally in orthopaedic or medical devices industry, where you have developed the ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities.

A Regulatory Affairs Certification (US or EU) is preferred.

What Will Make You Successful

  • Strong interpersonal and communication skills
  • Team spirit
  • Experience with solving problems and concerns
  • Good computer skills, including Microsoft Office Suite
  • Proficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU
  • 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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