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Regulatory Affairs Specialist in Medical Devices

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark FERROSAN MEDICAL DEVICES AS Full time
Key Responsibilities:
  • Representing QC in product development projects across microbiology, sterilization, environmental monitoring, and design transfer to QC
  • Supporting R&D and Operations in microbiology, endotoxin testing, and monitoring of sterilization processes
  • Maintaining strong relationships with external collaborators and participating in audits
  • Providing guidance and support to QC technicians
  • Handling deviations, CAPAs, and changes while ensuring compliance
  • Validating and verifying microbial analytical methods and implementing new methods in QC