Regulatory Affairs Specialist

2 days ago


Stockholm, Stockholm, Sweden Adxto AB Full time

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Adxto AB. In this consulting assignment, you will play a pivotal role in ensuring regulatory compliance within the medical device and pharmaceutical industry.

Key Responsibilities:
  • Collaborate with cross-functional teams to gather regulatory intelligence and facilitate transition of Legal Manufacturer status for compliance purposes.
  • Compile and manage registration dossiers for multiple countries, coordinating with distributors until submission.
  • Handle legalization and apostille processes for regulatory submissions, assisting in drafting documents for non-EU markets.
  • Manage artwork requests to ensure compliance with regulatory updates, verifying and updating compliance-related information.
  • Ensure SPOR/PMS product master data cleansing, verifying and updating compliance-related information, completing missing data ahead of regulatory deadlines.
  • Draft SPOR SOPs and support regulatory data clean-up initiatives, verifying and compiling product master data for regulatory databases.

You will be working in a dynamic and supportive environment, driving compliance and innovation in a rapidly evolving industry. The ideal candidate will have proven experience in Regulatory Affairs within Medical Devices and/or Pharmaceuticals.



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