Director of Regulatory Affairs HealthTech

1 week ago

Muscat, Oman Foreground LLC Full time

Foreground is partnering with a GCC-based digital health company delivering telemedicine, e-pharmacy, and diagnostic services to appoint a detail-oriented and cross-border experienced Director of Regulatory Affairs, based in Muscat. With the company expanding its operations across Oman, Saudi Arabia, and the UAE, this role plays a critical part in ensuring legal, ethical, and timely market access for innovative digital healthcare solutions across the region. Role Purpose To lead the companys regulatory strategy, compliance frameworks, and health authority engagement across markets, ensuring the timely registration and legal clearance of all products, platforms, and services in line with public health, data privacy, and telehealth-specific standards. Key Responsibilities Define and execute the regulatory roadmap for Oman and the wider GCC, covering product approvals, platform licensing, and post-market surveillance for all HealthTech services. Act as the primary interface with the Ministry of Health (MOH), DGPA, and other health authorities across the region, managing submissions, renewals, and audits. Oversee the classification and documentation of digital platforms, software as a medical device (SaMD), and remote diagnostics in line with global and regional frameworks. Lead cross-functional regulatory support during product development, localization, and commercialization stages, working closely 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 ethical telemedicine policies, advising senior leadership on compliance risks and market entry feasibility. Manage external regulatory consultants and advisors where applicable to support speed-to-market and localization needs. Ideal Candidate Profile 1015 years of regulatory affairs experience in the healthcare, pharmaceutical, or medtech sector, with a minimum of 3+ years in the GCC. Experience with HealthTech or digital health platforms is strongly preferred. Deep knowledge of local and international regulatory frameworks, including those related to medical device software, data privacy (GDPR, local laws), and cross-border health services. Bachelors degree in Pharmacy, Biomedical Engineering, Public Health, or Regulatory Affairs; postgraduate qualification is an advantage. Strong interpersonal and advisory skills; able to liaise with regulators, executive teams, and internal developers. Fluent in English; Arabic fluency is a plus, particularly for regional regulatory engagement.

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