Director of Regulatory Affairs HealthTech (DRA001)

Foreground Consultancy; Muscat; On-site; USD 120,000 - 180,000; Full time

Job summary

A leading GCC-based digital health company is seeking a Director of Regulatory Affairs based in Muscat. The role is critical in leading regulatory strategy and compliance for telemedicine and digital healthcare solutions, requiring extensive experience and knowledge of local and international regulatory frameworks.

Qualifications

• 10-15 years of regulatory affairs experience in healthcare, with 3+ years in the GCC.
• Experience with HealthTech or digital health platforms is strongly preferred.
• Deep knowledge of regulatory frameworks related to medical device software.

Responsibilities

• Define and execute the regulatory roadmap for Oman and the wider GCC.
• Act as the primary interface with health authorities, managing submissions and audits.
• Monitor changes in health regulations and advise senior leadership on compliance risks.

Skills

Licensing

Compliance

Operations

Renewals

Classification

Quality Assurance

Strategy

Documentation

Education

Bachelor's degree in Pharmacy

Biomedical Engineering

Public Health

Regulatory Affairs (postgraduate qualification)

Job description

Job Description:

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 company's 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

• 10-15 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.
• Bachelor's 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.

Required Skills include Licensing, Compliance, Operations, Renewals, Classification, Pharmacy, Protection, Assurance, Approvals, Registration, Healthcare, Product Development, Developers, Quality Assurance, Strategy, Regulations, Documentation, Software, Engineering, Leadership, and Training.