Head of Regulatory & Compliance
Cairo, Egypt
Head of Regulatory & Compliance
Cairo, EgyptPosted 2 days ago1 open position
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Job Description
Multinational medical device company is looking for an experienced Head of Regulatory & Compliance is responsible for:
- Ensuring the company’s adherence to global medical device regulations (FDA, EU MDR, ISO 13485, EDA, etc.)
- Mitigating legal and compliance risks, and leading a team to maintain a robust Quality Management System (QMS).
- This role serves as the primary point of contact for regulatory agencies, oversees compliance strategy, and ensures seamless alignment between Legal, Quality, and R&D teams.
Department: Legal & Compliance
Reports To: CEO
Location: Remote
Employment Type: Full-time
Key Responsibilities:
- Regulatory Strategy & Compliance Develop and execute a global regulatory compliance strategy for medical devices, including FDA (21 CFR Part 820), EU MDR/IVDR, and other international standards. Lead submissions, audits, and inspections (FDA Notified Bodies, ISO 13485 certifications). Ensure post-market surveillance (PMS) compliance, including adverse event reporting (MDR, Vigilance). Monitor emerging regulations and implement necessary policy changes.
- Legal & Compliance Risk Management Ensure compliance with anti-bribery (FCPA, UKBA), GDPR, and HIPAA. Review and approve contracts, supplier agreements, and distributor compliance. Mitigate product liability risks and support litigation preparedness.
- Quality Management System (QMS) Oversight Maintain and improve the eQMS (electronic Quality Management System) to ensure compliance with ISO 13485. Oversee CAPA (Corrective and Preventive Actions), non-conformances, and risk management (ISO 14971). Conduct internal audits and manage external regulatory inspections.
- Team Leadership & Cross-Functional Collaboration Manage a team of Regulatory Affairs Specialists, Compliance Officers, and QA professionals. Collaborate with R&D, Clinical, and Manufacturing teams to ensure compliance in product development. Train employees on regulatory requirements, compliance policies, and ethical standards.
- Operational Efficiency & Process Improvement Implement automation tools (eQMS, AI-driven compliance tracking). Optimize freelancer/outsourcing strategies for cost-effective compliance support. Develop KPIs and dashboards to track compliance performance.
Job Requirements
- Bachelor’s or Master’s degree in Law, Regulatory Affairs, Life Sciences, or Engineering.
- Preferred certifications: RAPS (RAC), AAMI, or ISO 13485 Lead Auditor.
- Experience: 15+ years in regulatory/compliance within the medical device industry.
- Proven track record of FDA/EU MDR submissions and successful audits.
- Experience with eQMS software (e.g., Greenlight Guru, Master Control). Strong knowledge of ISO 13485, ISO 14971, and GDPR.
- Language: Fluent in English (written & spoken)—mandatory for international submissions.
Skills & Competencies:
- Regulatory Expertise: Deep understanding of FDA, EU MDR, and global medical device laws.
- Leadership: Ability to manage a team and influence cross-functional stakeholders.
- Risk Management: Proactive in identifying and mitigating compliance gaps.
- Communication: Strong presentation skills for interactions with regulators and executives.
- Analytical Thinking: Data-driven decision-making for compliance optimization.
- Preferred Certifications (if any): RAC (Regulatory Affairs Certification) Training in FDA/EU MDR regulations.