Regulatory Compliance Officer

The Regulatory Compliance Officer supports the implementation, maintenance, and day‑to‑day operation of Eyes of AI’s Quality Management System (QMS) to ensure ongoing compliance with international medical device regulations and standards. This role focuses on executing routine quality, regulatory, and documentation activities that enable the safe and effective delivery of AI-powered Software‑as‑a‑Medical‑Device (SaMD) solutions. This is a part-time role with the potential to transition to full-time based on performance and business needs.

Key Responsibilities

• Support day-to-day operation and maintenance of the QMS.
• Maintain QMS documentation, including document control, change control, and record-keeping.
• Administer training records, QMS logs, and meeting documentation (agendas, minutes, action tracking).
• Log and track quality events (nonconformances, complaints, deviations, CAPA actions) and follow up on due items.
• Assist with risk management activities and updates to risk files, traceability matrices, and related records.
• Help compile and organise technical documentation to support regulatory submissions and audits.
• Prepare and maintain audit files, track findings and actions, and support readiness for internal and external audits.
• Collaborate with product, engineering, clinical, and operations teams to ensure QMS processes are followed, and records are complete.
• Escalate issues, risks, and noncompliances to the Regulatory Compliance Quality Manager in a timely manner.

Qualifications & Experience

• Proven experience in quality and regulatory management within MedTech, SaaS, or related industries.
• Foundational understanding of quality management principles and interest in medical device regulations and standards.
• Familiarity with or exposure to ISO 13485, ISO 14971, IEC 62304, and relevant regulatory pathways (e.g. EU, TGA, FDA) is desirable.
• Experience working with structured documentation, records management, or QMS / compliance tools is an advantage.
• Strong attention to detail, organisation, and time management, with the ability to handle multiple tasks.
• Clear written and verbal communication skills suitable for regulatory-grade documentation and cross-functional collaboration.