Global Head of Compliance

1 week ago

Qesm st Nasser City Cairo, Egypt K Line Europe GmbH Full time

We're Hiring | Global Head of Compliance

We're now seeking an exceptional
Head of Global Compliance
to lead our worldwide compliance strategy and ensure our systems, culture, and operations meet the highest global standards.

Role Summary

This executive role carries full responsibility for developing, implementing, and continuously improving K-Line's global compliance and quality frameworks. You'll oversee Quality Management Systems (QMS), regulatory submissions, risk management, and compliance culture across all regions and business units.

Key Responsibilities

  • Global Compliance Strategy:
    Define and execute a risk-based compliance roadmap in alignment with corporate objectives and board oversight.
  • Regulatory Oversight:
    Lead global regulatory submissions (e.g., 510(k), CE Marking) and manage all FDA, Notified Body, and internal audits.
  • QMS Excellence:
    Maintain and elevate the global QMS in line with international standards.
  • Risk & CAPA Management:
    Drive proactive compliance risk management and oversee CAPA systems, recalls, and non-conformities.
  • Global Training:
    Build a compliance culture through worldwide training programs that promote ethics, accountability, and quality.

Compliance Standards

Expert knowledge in global standards and frameworks is essential:

ISO 13485 | ISO 14971 | MDSAP | US FDA 21 CFR Part 820 (QSR) | EU MDR/IVDR (Annex XIII) | Asia-Pacific regulations (PMD Act, NMPA)

Qualifications

  • 10+ years of compliance experience, including 4+ years in a senior global role.
  • Proven leadership in multinational compliance, risk, and audit programs.
  • Fluent in English with strong strategic, analytical, and communication skills.

Preferred Certifications

  • Certified Compliance & Ethics Professional (CCEP)
  • Regulatory Affairs Certification (RAC)
  • Lead Auditor (ISO 13485 or equivalent)

If you're ready to lead a world-class compliance Team that drives integrity and innovation globally, we'd love to hear from you.


#GlobalCompliance #MedicalDevices #QualityLeadership #RegulatoryAffairs #KLineCareers

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