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Compliance Manager (Healthcare)

Europe Europe (remote) Ukraine Quality Management
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Необхідні навички

ISO 13485 / strong
IEC 62304 / strong
GxP / strong

We are looking for an experienced Compliance Manager to help us build QMS in accordance with healthcare software standards and regulations.

You will manage, design, and implement compliance policies and procedures, internal audits, and risk assessments in alignment with ISO 13485 and IEC 62304 standards.

Вимоги

  • Regulatory Knowledge:
    • in-depth understanding of ISO 13485, IEC 62304, GxP guidelines and regulations
  • Quality Management Systems (QMS):
    • experience in establishing and maintaining QMS compliant with ISO 13485, GxP, IEC 62304, and 21 CFR 820
  • Risk Management:
    • proficiency in conducting risk assessments and implementing risk management processes
  • Computer System Validation (CSV):
    • familiarity with the principles and practices of computer system validation related to GxP
  • Compliance with International Standards:
    • knowledge of international regulatory requirements relevant to ISO 13485, GxP, IEC 62304, and 21 CFR 820
  • Auditing:
    • strong background in conducting internal and external audits under ISO 13485, GxP, IEC 62304, and 21 CFR 820 standards
  • Communication Skills:
    • ability to communicate complex regulatory requirements clearly and effectively

Обов'язки

  • Interpreting and Implementing Regulations:
    • stay updated with ISO 13485, IEC 62304, and GxP regulations to ensure compliance
    • translate complex ISO 13485 and IEC 62304 requirements into actionable policies and procedures
  • Policy Development:
    • develop and maintain compliance policies, procedures, and guidelines for ISO 13485 and IEC 62304
  • Monitoring and Auditing:
    • monitor ongoing compliance with ISO 13485, IEC 62304, and GxP
    • conduct internal audits to identify compliance gaps and areas for improvement
  • Training and Education:
    • train employees to understand and adhere to ISO 13485 and IEC 62304 compliance requirements
    • educate staff on the implications and consequences of non-compliance
  • Risk Assessment and Management:
    • identify potential compliance risks related to ISO 13485, IEC 62304, and GxP
    • develop and implement strategies to mitigate identified risks
  • Staying Current with Regulatory Changes:
    • keep abreast of changes in ISO 13485, IEC 62304, GxP, and related regulations or best practices

Чому ми

  • Різноманітність доменів та бізнесу
  • Великий вибір технологій
  • Медична та юридична підтримка
  • Круте та живе ком'юніті професiоналiв
  • Безперервна освіта та можливість росту
  • Гнучкий графік
  • Віддалена робота
  • Стильний та комфортний офіс (для твого комфорту вибору звiдки працювати)
  • Спортивні заходи та спільноти

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