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PaxeraHealth Regulatory Manager in Cairo, Egypt

Job Description:

  1. Compliance Management
  • 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.

    1. Quality Assurance
  • 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.

    1. Risk Management & Reporting
  • 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.

    1. Collaboration & Leadership
  • 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.

    1. Process Improvement
  • 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.

    Qualifications and Skills:

  • 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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