Senior Regulatory Specialist MedTech Role

4 days ago


Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

We are seeking a Senior Regulatory Affairs Specialist in Medical Technology to develop and implement regulatory strategies, providing guidance on regulatory matters throughout the product lifecycle of medical devices.

About the Role:
  • This role requires collaboration with license partners as the Regulatory Affairs Expert, ensuring compliance with healthcare regulations set by relevant agencies.

Main Responsibilities:

  • Serve as the primary point of contact for regulatory activities, including regular meetings with license partners.
  • Develop, submit, and maintain product registrations for new and existing products during development and licensing activities.
  • Conduct regulatory reviews and approvals of product labeling and marketing materials for new products and licensing activities.

Key Requirements:

  • Proven experience in regulatory affairs, particularly in the medical technology industry.
  • Excellent communication and project management skills.
  • Able to work independently and collaboratively within a team environment.


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