Regulatory Affairs Specialist for HealthTech

3 days ago

Muscat, Muscat, Oman beBeeRegulatory Full time
Job Description

We are seeking an experienced Regulatory Affairs Specialist to join our team. The successful candidate will lead our regulatory strategy, ensuring timely registration and clearance of our products and services in the GCC region.

The ideal candidate will have a strong background in regulatory affairs within the healthcare or pharmaceutical sector, with at least 10-15 years of experience and 3+ years in the GCC.

Key responsibilities will include defining and executing the regulatory roadmap for Oman and the wider GCC, managing submissions, renewals, and audits, and overseeing the classification and documentation of digital platforms and software as medical devices.

The selected individual will also lead cross-functional regulatory support during product development, localization, and commercialization stages, and develop internal governance processes, regulatory training, and compliance reporting tools.

A bachelor's degree in Pharmacy, Biomedical Engineering, Public Health, or Regulatory Affairs is required, and a postgraduate qualification is an advantage.

  • Regulatory Affairs Expertise: In-depth knowledge of local and international regulatory frameworks, including those related to medical devices, software, data privacy, GDPR, local laws, and cross-border health services.
  • Strategic Leadership: Ability to lead cross-functional teams and drive regulatory strategies to achieve business objectives.
  • Communication Skills: Excellent interpersonal and advisory skills, with the ability to liaise with regulators, executive teams, and internal developers.
  • Linguistic Skills: Fluency in English, with Arabic fluency being a plus, particularly for regional regulatory engagement.

Ideal Candidate Profile

We are looking for a highly experienced individual who can drive our regulatory strategy forward and ensure compliance with relevant regulations.

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