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Profile Details
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USD 50 /hr
Hire Hana A.
Malaysia
USD 50 /hr

Regulatory affairs specialist with 8 years of experience in medical devices and pharma registration in ASEAN region.

Profile Summary
Subject Matter Expertise
Services
Writing Technical Writing
Consulting Scientific and Technical Consulting, Regulatory Consulting
Work Experience

Executive Regulatory Affairs

Astramern Sdn Bhd

May 2020 - Present

Executive Regulatory Affairs

AJ Research & Pharma Sdn Bhd

June 2016 - August 2019

Regulatory Executive.

Boehringer Ingelheim

September 2015 - June 2016

Executive Regulatory Affairs

Zuellig Pharma Ltd

November 2013 - August 2015

Education

BSc in Biotechnology

Malaysia University of Science and Technology (MUST)

September 2010 - September 2013

Certifications

  • Awareness to Establishment on the Special Access and Conditional Approval

    Medical Device Authority

    August 2021 - Present

  • ISO 13485: 2016 Awareness Training

    Permata Biru Health Consult Sdn Bhd

    January 2021 - Present

  • ISO 13485 :2016 Internal Auditor Training

    Permata Biru Health Consult Sdn Bhd

    January 2021 - Present

  • Awareness on the Requirements of Good Distribution Practice of Medical Device (GDPMD)

    Permata Biru Health Consult Sdn Bhd

    September 2020 - Present

  • National Regulatory Conference 2018

    National Pharmaceutical Regulatory Agency (NPRA)

    October 2018 - Present

  • Seminar with Medical Device Industry 2018

    Medical Device Authority

    April 2018 - Present

  • MMDA Countdown to Full Implementation of Medical Device Act

    Malaysia Medical Device Association

    March 2018 - Present

  • Product Labelling and Hands on Training

    International Food Safety Training Centre (IFSTC), Ministry Of Health Malaysia

    September 2017 - Present

  • Halal Assurance Management System

    Al Hamra Management Services PLT

    August 2016 - Present

  • Training on Medical Device Regulation and Registration of IVD under Medical Device Act 2012

    Medical Device Authority

    June 2014 - Present