Senior Regulatory Specialist

8 hours ago


Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time
Med Tech Regulatory Compliance Specialist

This is an excellent opportunity to work with an innovative Swedish medtech company that has high growth potential.

The purpose of this role is:

  • To be responsible for regulatory strategy and provide guidance on regulatory affairs matters throughout the life cycle of medical devices.
  • To act as a Regulatory Affairs Expert with new and existing license partners and ensure compliance with relevant laws and regulations.

Main tasks and responsibilities:

  • Be the main contact for regulatory affairs activities, including participating in regular meetings with license partners.
  • Develop, create, submit, and maintain product registrations for the company's products during new product development and line extensions for licensing activities.
  • Review and approve product labeling and marketing material for new products and licensing activities.
  • Create and submit changes or requested documentation to regulatory agencies and respond to queries and requests from those upon assignments.
  • Monitor new and changed regulatory requirements and guidelines in key markets, and communicate these changes to license partners when required.
  • Maintain technical files and regulatory strategies for medical devices for license partners.


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