Regulatory and Quality Assurance (QA) Manager

We are looking for Regulatory and Quality Assurance Manager to join our growing team. In this role, you will be responsible for ensuring compliance with global regulatory requirements and maintaining high-quality standards across all aspects of medical device development, manufacturing, and post-market activities.

• Prepare and submit regulatory filings in accordance with FDA, EU MDR, and other applicable global regulations.
• Monitor regulatory changes and ensure timely implementation of new requirements.
• Maintain up-to-date regulatory documentation and product registrations.
• Interface with regulatory agencies.

• Maintain and improve the Quality Management System (QMS) to comply with ISO 13485 and other applicable standards.
• Lead and support internal audits, supplier audits, and external audits.
• Manage CAPA (Corrective and Preventive Action) processes including root cause analysis and effectiveness checks.
• Oversee document control, training, complaint handling, non-conformances, and change management processes.
• Support design control, validation/verification activities, and risk management for new and existing products.

• B.Sc. in Biomedical Engineering or medical and biological sciences - A must
• proven experience in Regulatory Affairs and/or Quality Assurance in the medical device industry.
• Strong knowledge of FDA regulations, EU MDR, ISO 13485, and related standards.
• Experience with regulatory submissions and audit conduct.