RA/QA Specialist (1 year contract) (Medical Devices)

• US MNC with a global footprint and a growing SEA presence
• Regional RA/QA role covering Asia’s emerging markets
• 1 year contract
• Base salary up to $6,000/month + Completion Bonus

We are partnering with a global medical device company operating in over 100 countries with a global headcount of over 40,000 employees. With their regional sales office in Singapore and a growing presence across Southeast Asia, they are known for their extensive portfolio of high-quality medical products and clinical solutions across multiple care settings. Currently, they are looking to bring on a Regional QA / RA Specialist on a 1-year contract to provide maternity cover & additional support for their Asia’s QA/RA function.

Responsibilities

Reporting to the Regional RA/QA Manager, you will support regulatory and quality activities across Southeast Asia, working across two key areas. On the Regulatory Affairs side, you will prepare and submit product registration and renewal documentation to local authorities across the region, liaising with corporate offices, internal departments, and manufacturing sites to obtain the necessary documentation. You will also review product changes for registration implications, maintain product licence records and submission dossiers, monitor evolving regulatory requirements, and ensure 3PL warehouse labels remain compliant and up to date.

On the Quality side, you will support the maintenance of the Quality Management System (QMS) in line with ISO 13485 and corporate standards, conduct internal audits at 3PL warehouses and distributors, manage the end-to-end customer complaint handling process in collaboration with regional stakeholders, and support deviation and rework reviews to ensure compliance with regional procedures.

Requirements

The ideal candidate is someone with 3 to 6 years of experience in Regulatory Affairs and/or Quality Assurance within the Medical Devices industry, with solid hands-on knowledge of product registration processes and Quality Management Systems (ISO 13485). Familiarity with ASEAN regulatory requirements is essential; knowledge of US FDA or EU MDR frameworks will be an advantage. You should be comfortable working in a cross-functional, regional MNC environment, and able to hit the ground running given the contract nature of the position

                 
If you would like to be considered for this opportunity, please apply to the advertisement or forward a copy of your full CV to Ops@hunttalentpartners.com.

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