Mimi Ridhwan

Quality Assurance & Regulatory Affairs (MY / IDN / BN) @ bioMérieux

About

Experienced Quality Assurance & Regulatory Affairs with a demonstrated history of working in the medical device industry. Skilled in Internal Audit, ISO 9001, ISO 13485, and GDPMD. Strong regulatory experience supporting medical device compliance in Malaysia and Indonesia, with hands-on expertise in regulatory registration, renewals, and change notifications for both medical devices and in vitro diagnostic (IVD) devices.

Country

Malaysia

City

Federal Territory of Kuala Lumpur

Industry

Medical Device

Skill

Event Planning, Internal Audit, Conformity Assessment, Biocompatibility, ISO 13485, ISO 9001, Medical Devices

Experience

Quality Assurance & Regulatory Affairs (MY / IDN / BN)

bioMérieux

2022-2 - Present · 4 yrs 8 mos

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Responsible for quality processes in Malaysia, Indonesia, and Brunei, including internal, external and distributor audits. Overseeing regulatory activities including registrations, renewals, and change notifications for in vitro diagnostic devices.

Regulatory Affairs Specialist (MY)

ZEISS Medical Technology

2020-12 - 2022-2 · 1 yr 3 mos

Malaysia

Responsible for quality processes in Malaysia including internal and external audits. Overseeing regulatory activities including registrations, renewals, and change notifications for active and implantable medical devices.

New Business & Product Development

Bio-Collagen Technologies; subsidiary of Pharmaniaga Berhad

2016-12 - 2020-12 · 4 yrs 1 mo

Collaborated cross-functionally to ensure quality and regulatory compliance for animal-based wound dressings manufacturing site. Coordinator for ISO 10993 biocompatibility studies with Universiti Kebangsaan Malaysia. Coordinator for CME and awareness events across Malaysia. Acted as liaison with business partners to support successful distributorship collaborations.