Senior Regulatory Affairs Manager EMEA

il y a 4 jours


Lyon, Auvergne-Rhône-Alpes, France Talents Solutions Temps plein

About the Role:

Talents Solutions is seeking a highly skilled Senior Regulatory Affairs Manager to join our team in the EMEA region. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with European regulations and guidelines for medical devices.

Key Responsibilities:

  • Manage regulatory activities related to the design, manufacture, and distribution of custom-made products in the EMEA region.
  • Develop and maintain European regulatory processes to ensure compliance with regional activities.
  • Supervise regulatory activities linked to the import and distribution of products within the EU.
  • Act as the primary contact for all regulatory requests related to European operations activities.
  • Manage European regulatory surveillance and ensure the appropriate regional application of new or revised regulatory requirements.

Requirements:

  • Minimum 7 years of experience in Regulatory Affairs positions in the medical device industry.
  • Excellent knowledge of the regulatory and normative framework of Medical devices in Europe.
  • Ability to understand and interpret new requirements and regulations.
  • Fluent in French and English.
  • Experience in team management.

Why Join Us:

  • Enjoy a supportive work environment with flexible office options.
  • Work with a manager who is passionate about helping her team develop their skills and grow in their careers.
  • Manage key responsibilities and lead impactful projects.
  • Thrive in a fun, collaborative atmosphere where innovation is at the heart of everything we do.


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