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PaxeraHealth Logo PaxeraHealth · Quality Control

Regulatory & Compliance Manager

Egypt, Cairo · Job Posted December 11, 2025
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Job Responsibility

  • Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies
  • Lead efforts to obtain and maintain certifications (e.g., ISO 9001, ISO 27000, ISO 13485, FDA, MDR, and other relevant quality/compliance standards)
  • Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement
  • Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings
  • Monitor and interpret changes in laws, regulations, and industry standards
  • advise management on compliance implications
  • Implement and manage the company’s Quality Management Systems (QMS)
  • Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks
  • Conduct regular internal audits and assessments to evaluate compliance and certification readiness
  • Drive continuous improvement in quality processes through monitoring, feedback, and corrective action
  • Develop and implement a risk management strategy to address potential non-compliance or quality issues
  • Maintain a compliance and certification risk register, ensuring risks are documented and mitigated
  • Monitor and report on the company’s compliance status, providing regular updates to senior leadership
  • Investigate and resolve compliance-related issues or incidents, ensuring thorough root-cause analysis and preventive measures
  • Partner with operations, product, and cross-functional teams to embed compliance into daily workflows
  • Act as the primary liaison for regulatory bodies, certification auditors, and external inspections
  • Provide training, awareness programs, and guidance to employees on compliance standards, policies, and regulatory requirements
  • Foster a culture of integrity, accountability, and continuous learning across the organization
  • Lead continuous improvement initiatives to streamline compliance and certification processes
  • Enhance efficiency by automating and simplifying compliance workflows where possible
  • Stay updated on new regulations, compliance frameworks, and industry trends to anticipate and prepare for potential business impacts
  • Benchmark internal processes against best practices and recommend process optimizations

Requirements

  • Bachelor’s degree in compliance, regulatory affairs, business administration, or related field
  • At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry
  • Strong knowledge of industry regulations, quality standards (ISO), and compliance processes
  • Experience with obtaining ISO 9001, ISO 27000, ISO 13485, FDA, MDR
  • Excellent English Language
  • Excellent organizational, leadership, and communication skills
  • Ability to manage multiple projects and deadlines in a fast-paced environment
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