Asla T A

Planned career break for family and maternity responsibilities, while engaging with medical-device regulatory developments and pursuing relevant professional learning to stay updated in the field.

• Led the preparation and submission of cybersecurity deliverables for medical devices containing software, ensuring compliance with US FDA regulations and enhancing product security assurance.
• Prioritised tasks through effective time management, ensuring timely delivery of project milestones.
• Contributed to brainstorming sessions, generating innovative ideas and solutions that enhanced project outcomes.
• Worked closely with cross-functional teams fostering better team collaboration.
• Created comprehensive technical documentation for future reference and training purposes.
• Facilitated knowledge sharing and skill development among peers, strengthening team capabilities and collaborative success.

• Supported global regulatory submissions for APAC, EMEA, LATAM, and other regions in accordance with EU MDR requirements.
• Prepared STED analysis, GSPR analysis, GAP analysis, summary documents, and Global Submission Summary Documents.
• Worked with tools such as AGILE, CALYX, RAD D2, MRCS D2, ENOVIA, and MCRI Cabinet for regulatory project activities.

• Remediation of EU IVDR 2017/746
• Construction and peer review of STED, GSPR and Performance Evaluation documents for Diagnostic devices in accordance with EU IVDR 2017/746
• Prepared and submitted regulatory file applications and supporting documents to Notified body, ensuring compliance with regulatory standards.
• Expertise in systematic literature review for clinical writing of IVD medical devices
• Standards exposure: ISO 13485, ISO 14971, ISO 15223, ISO 20916, Medical Device-SDLC IEC 62304, ISO 18113-1, ISO 18113-2
• Collaborated with internal functional areas to produce and review regulatory documents, meeting project timelines and enhancing cross-departmental communication.
• Proficiency in applicable computer and database applications (ie., MS Word, MS Excel, MS PowerPoint, MS Visio, and Adobe Acrobat PDF)
• Actively involved in Cross Functional Team meetings and managed team with project related activities efficiently
• Comprehensive Knowledge on classification of IVD/medical devices
• Supported medical device classification, technical justifications, rationale documents, and IFU redlining.
• Trained colleagues and new resources on project requirements, facilitating knowledge transfer through interactive training sessions to improve team competency.

• Installed, tested, calibrated, maintained, and repaired biomedical equipment to support safe clinical operation.
• Performed preventive maintenance, troubleshooting, functional testing, and repair of equipment malfunctions.
• Prepared technical reports by collecting, analyzing, and summarising equipment-related information and data.