Summary
Overview
Work History
Education
Skills
Websites
Certification
Projects & Seminar
Interests
Timeline
Generic

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

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

Magazine Sketching

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 -

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Asla T AMedical Device Regulatory Affairs