Regulatory Compliance Expert

2 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Key Responsibilities
  • Develop, manage, and review Quality Management System (QMS) processes,
  • Ensure QMS compliance with medical device regulations (MDR, ISO 13485, FDA),
  • Support the management of CAPA, non-conformance, change management, and audits,
  • Review QMS efficiency, focusing on key processes and reporting,
  • Conduct QA reviews, investigate non-conformance, and manage CAPA,
  • Serve as an internal auditor and coordinate external audits,
  • Analyze quality data and identify training needs,
  • Address Quality Assurance and Regulatory Compliance issues,
  • Initiate and/or lead projects to improve quality assurance processes,
  • Coordinate and support on-site audits conducted by external providers.


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