Regulatory Affairs Expert

18 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time

Key Responsibilities:

  • Develop and manage Quality Management System (QMS) processes to ensure compliance with medical device regulations (MDR, ISO 13485, FDA).
  • Support management of CAPA, non-conformance, change management, and audits.
  • Conduct QA reviews, investigate non-conformance, and manage CAPA.
  • Analyze quality data and identify training needs.
  • Address Quality Assurance and Regulatory Compliance issues.
  • Initiate and lead projects to improve quality assurance processes.
  • Coordinate and support on-site audits conducted by external providers.


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