Regulatory Affairs Expert Medical Technology

4 days ago


Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

Bondi Chefrekrytering AB is seeking a highly skilled Senior RA Specialist to join our team in the rapidly growing field of Medical Technology. This exceptional opportunity allows you to contribute to pioneering work at an exciting phase of growth.

Job Summary:
  • This position requires developing and implementing regulatory strategies, providing guidance on regulatory matters throughout the product lifecycle of medical devices.
  • The ideal candidate will collaborate with license partners as the Regulatory Affairs Expert, ensuring compliance with healthcare regulations set by relevant agencies.

Detailed Responsibilities:

  1. Serve as the primary point of contact for regulatory activities, including regular meetings with license partners.
  2. Develop, submit, and maintain product registrations for new and existing products during development and licensing activities.
  3. Conduct regulatory reviews and approvals of product labeling and marketing materials for new products and licensing activities.
  4. Prepare and submit changes or documentation to regulatory agencies, responding to queries and requests as assigned.
  5. Maintain technical files and regulatory strategies for medical devices for assigned license partners.

Reports to: Global Head of Quality & Regulatory Affairs.



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