Profile Details

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USD 40 /hr

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Hire Irene Y.

Malaysia

USD 40 /hr

Regulatory affairs professional with extensive knowledge in ISO 13485:2016 and the EU MDR.

Profile Summary

Regulatory technical writer with experiences in the medical device, pharmaceutical, and cosmetic industries. Demonstrate extensive knowledge in meeting the demand of stringent requirements of the ISO 13485, MDD and MDR, including risk management, post-market surveillance, biological evaluation and clinical evaluation. Proven track of record in successful product approval / registration with the Malaysia MDA and NPRA.

Subject Matter Expertise

• ★ Medical Devices
• ★ Regulatory Writing
• ☆ Product Compliance

Services

• Writing

Writing Technical Writing

Work Experience

Regulatory Technical Writer (MDD / MDR)

Oro Clean Chemie

November 2017 - October 2021

Regulatory Affairs Specialist

Lumine Japan

June 2014 - October 2017

Analytical Chemist

Dynamic Marvel Cekap

April 2007 - February 2014

Analytical Chemist

Malayan Pharmaceutical (Duopharma)

March 2004 - March 2007

Education

Master of Business Administration

University Malaya

January 2012 - January 2015

Bachelor of Science

Campbell University

January 2000 - January 2004

Certifications

• Certification details not provided.