Senior Regulatory Affairs Specialist (f/m/d)

Danaher UK

Krakow, Poland
Onsite
Regulatory compliance for medical devices
Product change control and iso standards
Regulatory assessment of product complaints
Cytiva, a part of Danaher UK, is seeking a Senior Regulatory Affairs Specialist in Krakow, Poland, to ensure global regulatory compliance for medical devices. The role requires a life sciences degree, 2-3 years of regulatory experience, and knowledge of quality systems and medical device regulations

Job Summary

  • At Cytiva, one of Danaher’s operating companies, the work saves lives by innovating for tangible impact in life sciences and biotechnology.
  • The Senior Regulatory Affairs Specialist manages regulatory compliance activities for medical devices, including product change assessments, complaint evaluations, and audit support.
  • The role offers the opportunity to work on meaningful challenges with a culture of belonging and continuous improvement.

Matching Summary

Match Score: 85

Cytiva, a part of Danaher UK, is seeking a Senior Regulatory Affairs Specialist in Krakow, Poland, to ensure global regulatory compliance for medical devices. The role requires a life sciences degree, 2-3 years of regulatory experience, and knowledge of quality systems and medical device regulations.

Skills & Requirements

Must-have

  • Regulatory compliance for medical devices
  • Product change control and ISO standards
  • Regulatory assessment of product complaints
  • Support regulatory audits and inspections
  • Fluency in English and Polish

Nice-to-have

  • Continuous improvement culture
  • Ability to present technical information clearly
  • Team collaboration and support
  • Knowledge of Danaher Business System

Key Requirements

  • Life Sciences degree or equivalent
  • 2-3 years regulatory or technical experience in healthcare/life sciences
  • Comprehensive knowledge of ISO 9001 and ISO 13485 quality systems
  • Working knowledge of global medical device regulations
  • Ability to travel up to 10% within EMEA

Work Rights

Not specified

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