Pre Market Quality And Regulatory Specialist (m/f/d)

Dedalus

Sarajevo, Bosnia and Herzegovina
3-5 years regulated industry experience
Iso 13485 iso 14971 iec 62304 knowledge
Medical device regulation mdr ivdr expertise
The role involves driving the implementation of the Dedalus Healthcare Quality Management System across sites in Sarajevo and beyond

Job Summary

  • The role involves driving the implementation of the Dedalus Healthcare Quality Management System across sites in Sarajevo and beyond.
  • Candidates will be accountable for compiling regulatory clearance documentation to achieve timely clearances for medical devices.
  • Dedalus fosters a diverse culture where employees are encouraged to learn, innovate, and make a meaningful difference in global healthcare.

Matching Summary

The role involves driving the implementation of the Dedalus Healthcare Quality Management System across sites in Sarajevo and beyond.

Skills & Requirements

Must-have

  • 3-5 years regulated industry experience
  • ISO 13485 ISO 14971 IEC 62304 knowledge
  • Medical Device Regulation MDR IVDR expertise
  • CAPA NC resolution management skills
  • English upper intermediate proficiency

Nice-to-have

  • GDPR and ISO 27001 awareness
  • FDA MHRA TGA regulatory knowledge
  • Strong problem solving abilities
  • Microsoft Office advanced skills
  • Independent deadline management

Key Requirements

  • Minimum 3-5 years in quality or regulatory affairs
  • Subject matter expert in healthcare quality standards
  • Experience with design control and risk management regulations

Work Rights

Not specified

Tailored Resume

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