Job Description
The Regulatory Compliance Quality Manager supports the implementation, maintenance, and day to day operation of the company’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.
Key Responsibilities
● Support the day to day operation and maintenance of the Quality Management System.
● Maintain QMS documentation, including document control, change control, and record keeping in accordance with regulatory standards.
● Administer training records, QMS logs, and meeting documentation including agendas, minutes, and action tracking.
● Log, track, and manage quality events including nonconformances, complaints, deviations, and Corrective and Preventive Actions (CAPA), ensuring timely follow up and closure of actions.
● Support the development, documentation, and monitoring of Corrective Action Plans to address audit findings, quality events, and regulatory observations.
● Assist with risk management activities, including updates to risk files, traceability matrices, and supporting documentation.
● Compile, organise, and maintain technical documentation required for regulatory submissions and quality audits.
● Prepare and maintain audit documentation, track audit findings, and coordinate follow up actions to ensure compliance.
● Collaborate with product, engineering, clinical, and operations teams to ensure QMS processes are followed and documentation remains complete and audit ready.
● Escalate issues, risks, and potential noncompliances in a timely and structured manner.
Qualifications and Experience
● Proven experience in quality and regulatory management within MedTech, SaaS, or related regulated industries.
● Practical experience working with Quality Management Systems used in medical device environments, including platforms such as Greenlight Guru or similar electronic QMS systems.
● Experience managing documentation and workflows related to Corrective Action Plans, CAPA processes, and audit remediation activities.
● Foundational understanding of medical device quality and regulatory standards including ISO 13485, ISO 14971, IEC 62304, and relevant regulatory pathways such as EU MDR, TGA, and FDA frameworks.
● Strong experience working with structured documentation, records management, and compliance tracking systems.
● Excellent attention to detail, organisation, and time management with the ability to manage multiple regulatory and documentation tasks simultaneously.
● Clear written and verbal communication skills suitable for regulatory grade documentation and cross functional collaboration.
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