Senior Regulatory Affairs Specialist (f/m/d)

Danaher

Krakow, Poland
Onsite
Regulatory compliance for medical devices
Quality systems knowledge iso 9001 and iso 13485
Regulatory assessment of product complaints
Cytiva, a subsidiary of Danaher, is seeking a Senior Regulatory Affairs Specialist in Krakow, Poland, to support global regulatory compliance for medical devices. The ideal candidate should have a background in life sciences, experience in regulatory affairs, and strong communication skills in English and Polish

Job Summary

  • The Senior Regulatory Affairs Specialist is responsible for supporting global regulatory compliance of Medical Devices placed on the market by Cytiva.
  • Working at Cytiva means being at the forefront of providing new solutions to transform human health and working on challenges that truly matter with people that care.
  • You will manage product change control assessments, oversee regulatory complaint assessments, support audits, and participate in implementing new regulatory systems.

Matching Summary

Match Score: 85

Cytiva, a subsidiary of Danaher, is seeking a Senior Regulatory Affairs Specialist in Krakow, Poland, to support global regulatory compliance for medical devices. The ideal candidate should have a background in life sciences, experience in regulatory affairs, and strong communication skills in English and Polish.

Skills & Requirements

Must-have

  • Regulatory compliance for medical devices
  • Quality Systems knowledge ISO 9001 and ISO 13485
  • Regulatory assessment of product complaints
  • Fluency in English and Polish
  • Support regulatory audits and reporting
  • Travel up to 10% within EMEA

Nice-to-have

  • Continuous improvement culture
  • Ability to present technical information clearly
  • Experience with regulatory RIM systems
  • Team collaboration and support
  • Customer-focused regulatory information provision

Key Requirements

  • Life Sciences degree or equivalent
  • 2-3 years regulatory or technical experience in healthcare/life sciences
  • Comprehensive knowledge of Quality Systems for medical devices
  • Working knowledge of global Medical Device regulations
  • Fluency in English and Polish
  • Ability to travel up to 10% within EMEA

Work Rights

Not specified

Tailored Resume

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