Regulatory & Compliance Manager

5 days ago

Cairo, Cairo, Egypt PaxeraHealth Full time 60,000 - 1,200,000 per year
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.
2. 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.
3. 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.
4. 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.
5. 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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