Assistant Manager, Regulatory Affairs & Quality Assurance (Medical Devices)

• Established Japanese Medical Devices MNC
• New headcount with regional scope across Asia
• Base salary up to $7,500/month + AWS + VB

We are partnering with a leading Japanese MNC in Medical Devices, operating across multiple markets with strong links to a global headquarters. The business plays a critical role in advancing hospital and chronic care solutions, combining deep clinical expertise with long-term investment in innovation, integrated care models, and digital enablement. As part of regional expansion plan, they are looking to hire a new Assistant Manager for the QA/RA team based in Singapore.

Responsibilities

Reporting to the QA / RA Manager, you will oversee the QA & RA function in managing complaint reporting, GDPMDS audits, change controls, and staff training. You will be responsible for analysing complaints and determining reportability, and reporting Field Safety Corrective Actions (FSCA) and adverse events to the relevant authorities when required.

You will also take ownership of product registration and market access approvals across designated countries, coordinating closely with HQ and OEMs to prepare and submit all required documents and certificates within stipulated timelines. In addition, you will review and approve post-market change notifications (including labelling changes), liaise with local regulatory authorities, and act as the Management Representative for the company, ensuring the organisation remains aligned with international regulations and standards.

Requirements

The ideal candidate is someone with at least 5 years of hands-on experience in Quality Assurance and Regulatory Affairs within the Medical Devices industry. You will need to have a solid working knowledge of GDPMDS, HSA regulations, and ASEAN regulatory requirements for medical device registration. Prior experience in handling product registrations, post-market surveillance, and FSCA reporting will be essential. As this role interfaces with both regional subsidiaries and HQ, you will also need to be a confident communicator with strong organisational skills and the ability to manage multiple priorities independently.

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

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