Director of Regulatory Affairs, HealthTech

About the role

A GCC-based digital health company delivering telemedicine, e-pharmacy and diagnostic services is looking for a Director of Regulatory Affairs based in Muscat, Oman. The company is expanding its operations across Oman, Saudi Arabia and the UAE, and the role ensures legal, ethical and timely market access for its digital healthcare solutions. The position is full-time and on-site.

Key responsibilities

• Define and execute the regulatory roadmap for Oman and the wider GCC, covering product approvals, platform licensing and post-market surveillance.
• Act as the main interface with the Ministry of Health, DGPA and other health authorities, managing submissions, renewals and audits.
• Oversee the classification and documentation of digital platforms, software as a medical device (SaMD) and remote diagnostics.
• Lead regulatory support during product development, localization and commercialization, working with product, engineering, legal and quality assurance teams.
• Develop internal governance processes, regulatory training and compliance reporting tools.
• Monitor changes in health regulations, data protection laws and telemedicine ethics, and advise senior leadership on compliance risks and market entry feasibility.
• Manage external regulatory consultants and advisors where applicable.

Required profile

• 10 to 15 years of regulatory affairs experience in healthcare, pharmaceuticals or medtech, with at least 3 years in the GCC.
• Experience with HealthTech or digital health platforms strongly preferred.
• Bachelor's degree in Pharmacy, Biomedical Engineering, Public Health or Regulatory Affairs; a postgraduate qualification is an advantage.
• Fluent English; Arabic is a plus.

Required skills

• Deep knowledge of local and international regulatory frameworks, including medical device software, data privacy (GDPR, local laws) and cross-border health services.
• Strong interpersonal and advisory skills, able to liaise with regulators, executives and developers.