Director of Regulatory Affairs HealthTech

3 weeks ago

Muscat, Muscat, Oman Foreground LLC Full time
Director of Regulatory Affairs HealthTech (DRA001)

Join to apply for the Director of Regulatory Affairs HealthTech (DRA001) role at Foreground.

Role Overview

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. The company is expanding across Oman, Saudi Arabia, and the UAE, making this role vital for ensuring legal, ethical, and timely market access for innovative digital healthcare solutions in the region.

Key Responsibilities
  • Define and execute the regulatory roadmap for Oman and the GCC, including product approvals, platform licensing, and post-market surveillance for all HealthTech services.
  • Act as the primary liaison with the Ministry of Health (MOH), DGPA, and other health authorities, managing submissions, renewals, and audits.
  • Oversee classification and documentation of digital platforms, software as a medical device (SaMD), and remote diagnostics, ensuring compliance with regional and global frameworks.
  • Lead cross-functional regulatory support during product development, localization, and commercialization, collaborating with product, engineering, legal, and quality teams.
  • Develop governance processes, regulatory training, and compliance reporting tools.
  • Monitor regulatory changes in health laws, data privacy, and telemedicine policies, advising leadership on compliance and market entry.
  • Manage external regulatory consultants to support market entry and localization efforts.
Ideal Candidate Profile
  • 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 is highly preferred.
  • Strong knowledge of regulatory frameworks related to medical device software, data privacy laws (GDPR and local laws), and cross-border health services.
  • Bachelor's degree in Pharmacy, Biomedical Engineering, Public Health, or Regulatory Affairs; postgraduate qualifications are advantageous.
  • Excellent interpersonal and advisory skills; capable of liaising with regulators, executive teams, and technical staff.
  • Fluent in English; Arabic proficiency is a plus for regional regulatory engagement.
Additional Details
  • Seniority Level: Director
  • Employment Type: Full-time
  • Job Function: Legal
  • Industries: Business Consulting and Services

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