Global Medical Devices MNC with strong growth plans in Asia
People management role across emerging markets
Base salary $8,000 - $10,000/month + Bonus

We are partnering with a global Medical Devices MNC with a wide range of medical and surgical devices across consumables and equipment. With a large global team of over 40,000 employees and more than 20 manufacturing sites worldwide, the business has a strong heritage of over 50 years and is now actively expanding its footprint across emerging Asia markets. As the regional team continues to grow, they are now looking for an experienced QA/RA Manager to lead their Quality and Regulatory function across the emerging markets.

Responsibilities

Reporting to the General Manager, the QA/RA Manager will be responsible for developing and executing regulatory strategies across Southeast Asia, overseeing product registrations, renewals, and license maintenance for hospital consumables (Class 1 – 3) across emerging markets. This includes preparing and submitting regulatory dossiers to local authorities via distributors and RA consultants, managing adverse events and field safety corrective action (FSCA) reporting, reviewing labels and marketing materials for regulatory compliance, and performing continuous regulatory intelligence scans.

On the quality front, the role is responsible for maintaining the Quality Management System (QMS) in alignment with corporate and regional standards, conducting internal audits across 3PL warehouses and distributors, and managing end-to-end complaint handling from receipt through investigation to resolution. As a people manager, you will lead and develop a small team of 3 across Singapore, Malaysia, and Korea, ensuring strong cross-functional collaboration with supply chain, sales, and corporate teams to support overall compliance and operational excellence.

Requirements

The ideal candidate is someone with minimum 5 – 8 years of combined QA and RA experience within the Medical Devices sector. You will need to have solid working knowledge of ASEAN Medical Device Directives, US FDA, and EU MDR regulations, and be familiar with ISO 13485 with internal auditor certification. Prior experience in people / team management is required given the team coverage across a few markets.

If you would like to be considered for this opportunity, please apply to the advertisement or forward a copy of your full CV to [HIDDEN TEXT].

Business Registration Number: 202509847W | Licence Number: 25S2778 | EA Registration Number: R1653095

Regulatory Affairs & Quality Manager (Medical Devices)