Compliance Expert in Medical Devices

3 days ago


Stockholm, Stockholm, Sweden Adxto AB Full time

Adxto AB is currently looking for a Compliance Expert in Medical Devices to join our consulting team. As a key player in regulatory project management, you will be responsible for ensuring compliance with MDR regulations and product master data requirements.

Responsibilities:
  • Facilitate cross-functional collaborations to gather regulatory intelligence, providing insights for local MDR registrations and regulatory updates.
  • Transition Legal Manufacturer status for compliance purposes, ensuring seamless coordination with external partners.
  • Manage registration dossiers for multiple countries, handling legalization and apostille processes for regulatory submissions.
  • Support the compilation of regulatory submission documents for non-EU markets, verifying and updating compliance-related information.
  • Cleanse and update SPOR/PMS product master data, completing missing data ahead of regulatory deadlines.

This consulting assignment offers an exciting opportunity to work with a leading company in the pharmaceutical industry, driving compliance and innovation in a rapidly evolving sector.



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