2 viewsTalent
Avishi P. — Mid-Level Medical Device Compliance Coordinator from Sri Lanka

Avishi P.

Mid-Level Medical Device Compliance Coordinator

Sri Lanka 1-2 years
Open to offersNew to Platform
Languages
English
Video Introduction
No video introduction yet
The candidate has not added a video.
Contact information and social networks are private. Connect to unlock.
Hidden

About

Avishi P. is a driven professional specializing in biomedical engineering and regulatory compliance, currently serving as a Medical Device Compliance and ISO Coordinator with experience as both an external consultant and an intern at Twinery, Innovations by MAS in Colombo. At Twinery, she ensures compliance with ISO 13485 standards and manages regulatory requirements for R&D medical devices through strategic coordination of Cognidox documentation management and collaboration with regulatory consultants. Her career began as a Biomedical Engineering Trainee at Asiri Surgical Hospital, where she contributed to device maintenance and audit preparations. Avishi's academic journey at General Sir John Kotelawala Defence University solidified her foundation, culminating in a Bachelor’s degree in Biomedical Engineering. She has co-authored papers presented at prestigious forums, showcasing her proficiency in cerebral MRI analysis and innovative device development, reinforcing her commitment to advancing healthcare technology.

Experience

  • MEDICAL DEVICE COMPLIANCE AND ISO COORDINATOR (EXTERNAL CONSULTANT)

    TWINERY, INNOVATIONS BY MAS · 2026 — Present
    Ensured compliance with ISO 13485 and related standards. Managed Cognidox as the primary repository for all medical device documentation (eQMS). Assisted in maintaining regulatory compliance with FDA, EMA, and MHRA requirements for R&D medical devices. Collaborated with regulatory consultants to secure compliance for medical and nonmedical devices.
  • MEDICAL DEVICE COMPLIANCE AND ISO COORDINATOR (INTERN)

    TWINERY, INNOVATIONS BY MAS · 2025 — 2026
    Monitored compliance with ISO 13485 and associated standards. Administered Cognidox as the centralized repository for medical device documentation (eQMS). Supported adherence to FDA, EMA, and MHRA regulatory requirements for R&D medical devices. Engaged with regulatory consultants to ensure compliance for various medical and nonmedical devices.
  • BIOMEDICAL ENGINEERING TRAINEE

    ASIRI SURGICAL HOSPITAL · 2023 — 2024
    Contributed to the repair and maintenance of medical devices. Aided in preparing procedures for the annual audit related to Australian Council on Healthcare Standards International (ACHSI) accreditation.

Skills & Expertise

Education

  • Bachelor of Science of Engineering Honours in Biomedical Engineering
    General Sir John Kotelawala Defence University · 2021 — 2025
  • General Certificate of Education (Advanced Level) Examination, Sri Lanka
    Visakha Vidyalaya · 2012 — 2020

Interested in this professional?

Sign in as an employer to save this profile or invite Avishi P. to a job.

Sign in as an employer