Clinical Trials & Regulatory Affairs Associate - On Job Training

Qualifications and Experience:

• Bachelor’s degree in Biomedical Engineering, Biotechnology, Medical Technology, Regulatory Affairs, or a Science Degree.
• Foundational understanding of clinical research processes, ISO 13485, GCP, and medical device regulations.
• Knowledge of EEG or neurotechnology is an advantage.
• Excellent organizational, analytical, and documentation skills.
• Strong written and verbal communication skills in English; Arabic proficiency preferred.
• Ability to work collaboratively in a cross-functional, fast-paced environment.
• High attention to detail, ethical awareness, and professional conduct in handling clinical data.

Additional Requirements

• Omani nationality – Preferred
• On-site work in Muscat and hospitals – Required 
  

Language Requirements

• English (fluent written and verbal) – Mandatory
• Arabic (fluent written and verbal) – Mandatory

Participate in internal audits, document control activities, and contribute to the Quality Management System (QMS). Coordinate with internal and external teams to ensure that clinical and regulatory activities align with the company’s project milestones. Support post-trial evaluation and post-market surveillance planning.

• Support the coordination and execution of NEXA clinical trials in collaboration with medical partners.
• Prepare, review, and maintain clinical trial documentation including protocols, case report forms, and consent documents.
• Assist in ethics committee submissions and ensure compliance with Good Clinical Practice (GCP) and ISO 14155 standards.
• Coordinate participant data collection, monitoring, and follow-up under the supervision of the Clinical Lead.
• Track and report trial progress, deviations, and incident reports in alignment with study protocols.
• Support the preparation of regulatory documentation for ISO 13485 certification, CE marking, and FDA device registration.
• Maintain accurate and version-controlled records for clinical and regulatory documentation.