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Asla T A
Medical Device Regulatory Affairs
Thrissur
Summary
Detailed-oriented Medical Device and IVD Regulatory Affairs Analyst with 3+ years of experience in medical domain with comprehensive technical knowledge in Medical Device and IVD Regulations especially IVDR 2017/746 and EU MDR 2017/745 along with knowledge in handling and troubleshooting of medical devices. Quickly learns and masters new technologies while working in both team and self-directed settings. Aims to pursue a challenging career and be a part of a progressive organization that gives a scope to enhance my knowledge and utilize my skills towards the growth of the organization.
Overview
4
4
years of professional experience
11
11
Certifications
4
4
Languages
Work History
Senior Engineer - Regulatory Affairs
Tata Elxsi
10.2023 - Current
- I have involved in the global regulatory submission support for APAC, EMEA, LATAM, and other regions as per EU MDR regulation
- Also have prepared STED analysis, GSPR Analysis, GAP Analysis, Summary documents and Global Submission Summary Document creation
- I am working with tools such AGILE, CALYX, RAD D2, MRCS D2, ENOVIA, MCRI Cabinet for project activities.
Product Regulatory Analyst
HCLTech
02.2021 - 08.2023
- 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
- 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
- Collaborate with internal functional areas to ensure the production and review of Regulatory documents within agreed upon timelines
- 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
- Knowledge on Documents, Rationales and Technical Justification reports
- IFU Redlining
- Trained colleagues and newly joined resources according to the project requirements and provided knowledge transfer to the team by conducting interactive training sessions.
Biomedical Engineer SOB
Moulana Hospital
09.2020 - 12.2020
- Supported patient diagnosis and treatment by installing, testing, calibrating and repairing biomedical equipment
- Maintained safe operation of equipment by completing preventive maintenance schedules, conducting tests and troubleshooting and repairing malfunctions
- Prepared report by collecting, analyzing and summarizing information and data.
Education
Bachelor of Technology - Biomedical Engineering
T.K.M Institute of Technology (University - KTU)
Kollam, Kerala 04.2001 -
Class 12 -
IES PUBLIC SCHOOL (University- CBSE)
Thrissur, Kerala 04.2001 -
Class 10 -
IES PUBLIC SCHOOL (University- CBSE)
Thrissur, Kerala 04.2001 -
Skills
Technical Skills
EU IVDR 2017/746
EU MDR 2017/745
Technical Documentation
Excellent Analytical and Problem Solving skills
Medical/Clinical Writing
Gap Assessment
Overview on MDR
Good Documentation Practice
Knowledge on MQMS ISO 13485, ISO 14971, ISO 15223, ISO 18113-1, ISO 18113-2, ISO 20916, Medical Device - SDLC IEC 62304
Knowledge on Biomaterials, Biosensors and Medical Robotics Designing- of basic electronic circuits, PCB circuit and layout design using Proteus
Basics in C/C and Embedded C
Handling and troubleshooting of medical devices
Proficiency in MS Office Tools (MS Word, MS Excel, MS PowerPoint), MS Visio and Adobe Acrobat PDF, Basics in LabVIEW
PMS-basics of complaint handling
Knowledge about DHF activities
Global regulatory submission support for APAC, EMEA, LATAM, and other regions
Soft Skills
Time Management
Creativity and Persistence
Communication skills
Ability to rapidly adapt to different situations
Flexibility and Dedication
Team Building and Leadership skills
Team management
Documentation Skills
Presentation skills
Team Building
Problem Solving
Certification
Advanced Lean Six Sigma Yellow Belt Live Certification Masterclass, Sparen & Gewinn Consulting
Projects & Seminar
- UG MAIN PROJECT : IoT based phototherapy machine for neonatal
- UG MINI PROJECT : A high-performance CNT based field emission X-ray tube in dental application with 3D imaging technique
- UG Seminar : A novel monolithic soft robotic thumb for an anthropomorphic prosthetic hand
Interests
Volunteering
Travelling
Drawing
Timeline
Senior Engineer - Regulatory Affairs
Tata Elxsi
10.2023 - Current
Product Regulatory Analyst
HCLTech
02.2021 - 08.2023
Biomedical Engineer SOB
Moulana Hospital
09.2020 - 12.2020
Bachelor of Technology - Biomedical Engineering
T.K.M Institute of Technology (University - KTU)
04.2001 -
Class 12 -
IES PUBLIC SCHOOL (University- CBSE)
04.2001 -
Class 10 -
IES PUBLIC SCHOOL (University- CBSE)
04.2001 -