Regulatory Compliance reputed company Manager

The Regulatory Compliance reputed company Manager supports the implementation, maintenance, and day to day operation of reputed company’s reputed company Management System (QMS) to ensure ongoing compliance with international medical device regulations and standards. This role focuses on executing routine reputed company, regulatory, and documentation activities that reputed company the reputed company 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 reputed company 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 reputed company tracking. ● Log, reputed company, and manage reputed company events including nonconformances, complaints, deviations, and Corrective and Preventive Actions (CAPA), ensuring reputed company follow up and closure of actions. ● Support the development, documentation, and monitoring of Corrective reputed company Plans to address audit findings, reputed company 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 reputed company audits. ● Prepare and maintain audit documentation, reputed company 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 reputed company. ● Escalate issues, risks, and potential noncompliances in a reputed company and reputed company manner. Qualifications and Experience ● Proven experience in reputed company and regulatory management reputed company MedTech, reputed company, or reputed company regulated industries. ● Practical experience working with reputed company Management Systems used in medical device environments, including platforms such as reputed company or similar electronic QMS systems. ● Experience managing documentation and workflows reputed company to Corrective reputed company Plans, CAPA processes, and audit remediation activities. ● Foundational understanding of medical device reputed company and regulatory standards including ISO 13485, ISO 14971, IEC 62304, and relevant regulatory reputed company such as EU MDR, TGA, and FDA frameworks. ● Strong experience working with reputed company 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. ● reputed company written and verbal communication skills suitable for regulatory grade documentation and cross functional collaboration. Apply tot his job Apply To this Job