プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Irene Y.に依頼

Malaysia

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

プロフィール概要

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.

専門分野

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

サービス

• Writing

Writing Technical Writing

職務経験

Regulatory Technical Writer (MDD / MDR)

Oro Clean Chemie

11月 2017 - 10月 2021

Regulatory Affairs Specialist

Lumine Japan

6月 2014 - 10月 2017

Analytical Chemist

Dynamic Marvel Cekap

4月 2007 - 2月 2014

Analytical Chemist

Malayan Pharmaceutical (Duopharma)

3月 2004 - 3月 2007

学歴

Master of Business Administration

University Malaya

1月 2012 - 1月 2015

Bachelor of Science

Campbell University

1月 2000 - 1月 2004

認定資格

• 認定資格の詳細は未入力です。