Healthcare Regulatory Strategist

3 days ago

Muscat, Muscat, Oman beBeeRegulatory Full time $100,000 - $125,000

Our digital health company is expanding its operations across Oman, Saudi Arabia, and the UAE. To support this growth, we are seeking a highly experienced Healthcare Regulatory Strategist. This role will play a critical part in ensuring legal, ethical, and timely market access for innovative digital healthcare solutions across the region.

Job Description:

We are looking for a detail-oriented professional to lead our regulatory strategy, compliance frameworks, and health authority engagement across markets. The successful candidate will ensure 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:

  • Develop 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.

Required Skills and Qualifications:

  • A minimum of 10 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.

About You:

  • You have a proven track record of success in regulatory affairs, with a strong understanding of the GCC market.
  • You are able to work effectively in a fast-paced environment, prioritizing tasks and managing multiple projects simultaneously.
  • You possess excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders at all levels.
  • You are passionate about digital health and committed to ensuring the safe and effective delivery of innovative healthcare solutions.

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