MDR and PMS Compliance Consultant

3 days ago


Stockholm, Stockholm, Sweden Adxto AB Full time

Adxto AB is currently seeking an MDR and PMS Compliance Consultant to join our consulting team. In this role, you will be responsible for ensuring compliance with MDR and PMS regulations, collaborating with cross-functional teams to gather regulatory intelligence.

Main 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.

The ideal candidate will have strong understanding of MDR regulations and product master data compliance, with experience in dossier compilation and regulatory submission processes.



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