ABOUT OCUMETRA

At Ocumetra, we are transforming the landscape of paediatric eye care with innovative, data-driven tools for myopia management. Our clinical decision support software empowers eye care professionals with actionable insights to improve vision outcomes in children. As we continue our growth journey, we’re looking for a dedicated Regulatory Associate to lead key regulatory initiatives and ensure compliance with global standards.

MINIMUM REQUIREMENTS:

• Bachelor’s degree in a relevant field (e.g. Biomedical Engineering, Life Sciences, Quality, Information Systems)
• Strong organizational skills with the ability to manage documentation and follow structured processes.
• Excellent written and verbal communication skills.
• Comfortable using software tools (MS Office, Confluence, Jira or similar platforms)

ABOUT THE ROLE

We are looking for a motivated, detail-oriented Regulatory Associate to support the ongoing development and maintenance of our Quality Management System (QMS) and Information Security Management System (ISMS). This role is ideal for someone looking to grow into the compliance and quality space within a regulated MedTech environment with exposure to ISO 13485, ISO 14971, IEC 62304 and ISO 27001 frameworks.
You will work cross-functionally to ensure our systems support compliance, efficiency, and risk management while helping drive a culture of quality and information security.

KEY RESPONSIBILITIES

• Support the day-to-day maintenance and administration of the QMS (in compliance with ISO 13485, ISU 14971, IEC 62304 and relevant regulatory requirements (e.g. EU MDR, FDA) and ISMS (in line with ISO/IEC 27001), ensuring documentation is current, organized, and audit-ready.
• Assist in the monitoring and tracking of QMS/ISMS compliance activities, including internal audits, CAPAs, change controls, and document control processes.
• Help coordinate QMS and ISMS process owners and monitor compliance to procedures across teams.
• Coordinate and follow up on routine QMS/ISMS tasks such as training record updates, document reviews, supplier evaluations etc.
• Support risk management documentation and traceability activities (e.g. risk files, risk control logs)
• Maintain records in relevant QMS ISMS tools (e.g. Jira, Confluence)
• Provide administrative and operational support for regulatory submissions, registrations, and communications with regulatory bodies, under the guidance of the Regulatory Affairs Officer.
• Help compile and maintain regulatory documentation, technical files, and internal records in line with applicable standards and regulations (e.g. ISO 13485, ISO 27001, GDPR, MDR/FDA if applicable).
• Assist in the preparation and scheduling of audits and inspections, supporting logistics, documentation, and follow-up actions.
• Support training initiatives and awareness programmes.
• Collaborate cross-functionally to support ongoing regulatory compliance projects and initiatives, contributing to a culture of quality and continuous improvement.
• Stay informed of relevant regulatory and standards updates and support impact assessments as directed.