Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Apply and implement IVDR 2017/746 and ISO 13485 standards.
Create and maintain DHF and manage design control processes.
Develop and maintain quality management system records for regulatory compliance.
Participate in regulatory audits, ensuring compliance with procedures.
Conduct compliance assessments, identify gaps, and develop action plans.
Lead quality training programs and support internal audits.
Continuously improve the quality management system to meet evolving standards.
Requirements:
Experience in DHF procedures, mitigation strategies, and timeline management.
Background in biology or chemistry for IVDR technical file remediation.
Strong knowledge of IVDR 2017/746, ISO 13485, DHF creation, and design control processes.
Provide reports, analysis, and feedback on compliance and KPIs.