Job Purpose:
We are seeking a highly motivated Regulatory and Quality Assurance Officer to ensure our products meet the highest quality standards and comply with regulatory requirements. The role involves executing test plans, identifying defects, maintaining quality management systems, and supporting regulatory compliance processes.
The vacancy will be offshore based in favor of Samir Group - KSA
Key Responsibilities:
- Implement and maintain quality management systems (QMS) and ISO standards.
- Conduct internal audits and support external audits for ISO 13485 / 19011 and related certifications.
- Prepare and review regulatory submissions and ensure compliance with local and international regulations.
- Identify, report, and follow up on product quality issues.
- Collaborate with cross-functional teams to maintain quality standards across all processes.
- Maintain accurate documentation and reports related to quality and regulatory affairs.