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Authoring, reviewing, and managing Clinical Evaluation / Post-Market Surveillance / Post-Market Clinical Follow-Up Plans and Reports (CEP, CER, Literature Search Protocol & Report, PMS Plan, PMS Report, PSUR, PMCF Plan, PMCF Report)
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Conducting gap analysis with the detailed comparison between the existing templates and the requirements outlined in the latest MDCG guidance and regulations, updating the templates, and addressing the Notify Body responses
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Working upon software medical devices clinical documentation preparation and reviewing of the technical documentation.
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Serving as clinical affairs personnel ensured keeping compliance with the quality management system (QMS) and/or establishing processes for continued improvement and maintenance of the QMS.
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Provided consultative services to departments and divisions, offering insights into complex business problems to communicate multifaceted strategies to key stakeholders that will advance translational and regulatory science across the organization.
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Performed QMS tasks according to international standards, i.e., ISO 13485, ISO 14971, MDD, and MDR, and updated the documents to keep regulatory compliance.
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Ensuring alignment with ISO 13485 (Quality Management Systems for Medical Devices), IEC 62304 (Software Lifecycle for Medical Devices), and ISO 14971 (Risk Management).
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Understanding and interpretation of FDA 21 CFR Quality Management System, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations applications.
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Experience in supporting/leading regulatory submissions such as EU MDR technical documentations and global registrations.
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Managed and maintained QMS documentation, including quality manuals, procedures, and work instructions, ensuring all documents were up-to-date and compliant.
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Performing regulatory database searches for adverse events/incidents/FSCA related to the device under evaluation and similar devices.