ADITHYA CASSANDRA MENON
Surgical Support/ Regulatory Affairs Executive / Post-Market Surveillance Specialist
Puchong
Summary
Results-driven Medical Science graduate with over 8 years of experience in Post-Market Surveillance, Surgical Support, Training, and Regulatory Affairs in the medical device industry. Skilled in FDA 21 CFR Part 803/820, ISO 13485, MDR submissions, CAPA processes, and audit readiness. Adept at managing global complaint handling, quality system documentation, and regulatory reporting using tools like EPIQ and SAP. Proven ability to lead teams, working cross-functionally with internal teams and global stakeholders, improve workflow efficiencies, and maintain strict compliance with regulatory bodies worldwide. Recognized for delivering strong technical support and maintaining high operational standards in fast-paced, regulated environments.
Overview
14
14
years of professional experience
Work History
Surgical Support / RA Exec / Logistic Exec
Humedical (M) Sdn Bhd
04.2024 - Current
- Returned to Humedical to continue delivering support and training for surgical teams, focusing on ENT specialty.
- Expert in high-end surgical technologies including: Medtronic: NIM 3.0, Nim Vital, IPC Console, IGS Navigation System.
- Smith & Nephew: Coblator, Werewolf Coblation System.
- Provided intraoperative technical assistance, equipment calibration, and troubleshooting during critical surgeries.
- Conducted in-service education and product training for healthcare professionals across various hospitals.
- Ensured sterile processing and operating theatre teams adhered to equipment handling protocols.
- Represented the company at CME/AGM events, works, and symposiums.
- Successfully built relationships with clinicians, generated revenue, and expanded the company’s hospital network through strategic market development.
- Processed and issued invoices, liaised with finance for payment tracking and vendor correspondence.
- Handled logistics and shipping coordination, including import documentation and delivery scheduling.
- Manage HR functions including staff leave records and attendance tracking.
- Coordinate and oversee Medical Device Authority (MDA) and GDPMD regulatory submissions and renewals.
- Serve as Admin Executive, managing critical documentation and office operations.
Product Surveillance Specialist II
Abbott Medical
05.2021 - 01.2024
- Additional Roles: Trainer, Lead Certifier, Reviewer
- Established and scaled the Product Performance Group for post-market surveillance operations in a new site.
- Managed end-to-end Medical Device Reports (MDRs) in compliance with FDA and global health authority regulations.
- Submitted 400+ MDRs monthly via EPIQ with zero late filings; ensured timely regulatory reporting.
- Complied with regulations including 21 CFR 803 & 820, ISO 13485, and internal SOPs.
- Performed detailed root cause analyses and supported CAPA for recurring product complaints or safety issues.
- Documented adverse events, identified device malfunction trends, and escalated to quality and legal teams.
- Collaborated with Quality Engineering, R&D, and Legal teams to close audit gaps and improve system processes.
- Contributed to Field Safety Corrective Actions (FSCA) and product enhancement projects through data insights.
- Mentored and certified new hires; reduced onboarding time by 30% with process improvements and SOP alignment.
- Supported multiple successful internal audits and regulatory inspections with no major findings reported.
Product Specialist & Surgical Support Exec
Humedical (M) Sdn Bhd
07.2017 - 04.2021
- Led product training, troubleshooting, and technical support for surgical equipment in ENT, neurosurgery, and orthopedics.
- Worked with systems from Medtronic, Smith & Nephew; ensured compliance with sterilization and safety protocols.
- Conducted risk assessments and collaborated with surgical teams to ensure regulatory-compliant practices.
- Managed consignment and inventory traceability to align with internal QA protocols and hospital policies.
- Organized CME events, technical workshops, and in-service education for clinical and surgical staff.
- Generated market intelligence reports to guide strategic decisions and expand regional client outreach.
Cabin Crew
Singapore Airlines
10.2011 - 10.2013
- Performed rigorous pre-flight safety checks, including first aid and emergency medical kits.
- Handled emergency and medical incidents onboard, ensuring regulatory reporting and documentation.
- Delivered customer service excellence in compliance with civil aviation authority guidelines across international flights.
Education
Bachelor of Medical Science (Hons) -
Management & Science University
Shah Alam, Selangor, Malaysia 04.2001 -
Diploma in Pharmacy -
Mahsa University College
Petaling Jaya, Selangor, Malaysia09-2010
Skills
- Regulatory Compliance FDA (21 CFR 803, 820), ISO 13485
- Medical Device Reporting (MDR), Vigilance Reporting
- Corrective & Preventive Actions (CAPA), Risk Management, FSCA
- Audit Support & Documentation Control (internal/external)
- Post-Market Surveillance
- Complaint Handling
- Tools: EPIQ, SAP, Microsoft Office, Sharepoint, One Note
- Cross-functional Collaboration & Stakeholder Engagement
- New Hire Training & SOP Development
- Root Cause Analysis & Continuous Improvement
- Team Management
Research
The Influence of Altitude on the Quality of Life Amongst Patients with Bronchial Asthma in Cameron Highlands & Klang.
Certifications Languages
- IELTS – Band 7.5
- MUET – Band 4
- Russian Language Course – Passed
- In Depth Training on General Medical Device – Certificate Awarded by Medical Device Authority (MDA) Malaysia
Timeline
Surgical Support / RA Exec / Logistic Exec
Humedical (M) Sdn Bhd
04.2024 - Current
Product Surveillance Specialist II
Abbott Medical
05.2021 - 01.2024
Product Specialist & Surgical Support Exec
Humedical (M) Sdn Bhd
07.2017 - 04.2021
Cabin Crew
Singapore Airlines
10.2011 - 10.2013
Bachelor of Medical Science (Hons) -
Management & Science University
04.2001 -
Diploma in Pharmacy -
Mahsa University College
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