Health Tech Regulatory Lead

2 days ago

Muscat, Muscat, Oman beBeeRegulatory Full time
Regulatory Affairs Director

This role involves overseeing the regulatory roadmap for Oman and the GCC, including product approvals, platform licensing, and post-market surveillance for all HealthTech services.

  • This includes managing submissions, renewals, and audits with the Ministry of Health (MOH), DGPA, and other health authorities.
  • Classification and documentation of digital platforms, software as a medical device (SaMD), and remote diagnostics must be ensured to comply with regional and global frameworks.
Key Responsibilities
  • Define and execute the regulatory strategy to ensure timely market access for innovative digital healthcare solutions in the region.
  • Act as the primary liaison with health authorities, managing relationships and ensuring compliance with regulations.
  • Lead cross-functional support during product development, localization, and commercialization, collaborating with teams to ensure regulatory requirements are met.
  • Develop governance processes, regulatory training, and compliance reporting tools to enhance the organization's regulatory capabilities.
  • Monitor regulatory changes in health laws, data privacy, and telemedicine policies, advising leadership on compliance and market entry strategies.
Ideal Candidate Profile
  • At least 15 years of experience in regulatory affairs in healthcare, pharmaceuticals, or medtech, with at least 3 years in the GCC.
  • Strong knowledge of regulatory frameworks related to medical device software, data privacy laws (GDPR and local laws), and cross-border health services is required.
  • 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.
Job Details
  • Seniority Level: Director
  • Employment Type: Full-time
  • Job Function: Legal
  • Industries: Business Consulting and Services

As a detail-oriented and experienced professional, you will play a vital role in ensuring the organization's products meet regulatory requirements and achieve market success.

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