Assistant Director, Quality & Regulatory Affairs (Medical Devices)

• Established Japanese Medical Devices MNC
• New leadership role for newly established Regional HQ in Singapore
• Base salary from $10,000 - $15,000/month

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 the establishment of their newly created Regional HQ in Singapore, they are now looking for a senior QA/RA leader to build and lead the Quality and Regulatory function across the region.

Responsibilities

Reporting to the Regional Managing Director, the Assistant Director of QA/RA will be responsible for providing strategic leadership and operational oversight of the Quality Management System and Regulatory Affairs functions across all manufacturing facilities and Sales & Marketing offices in the region. This includes establishing, implementing, and continuously improving the corporate QMS in compliance with ISO 13485, GMP, MDSAP, and GDPMDS requirements, leading Management Review processes, and ensuring robust implementation of CAPA, change control, non-conformance management, complaint handling, and post-market surveillance systems.

On the Regulatory Affairs front, the role is responsible for developing regulatory strategies to support new product development and market expansion, overseeing preparation and maintenance of product registrations, technical documentation, design dossiers, and regulatory submissions, and ensuring compliance with country-specific medical device regulations across the region. The position also provides manufacturing quality oversight across multiple sites while leading design control activities throughout the product lifecycle.

The role requires 30 – 40% travel across manufacturing sites and regional offices

Requirements

The ideal candidate is someone with minimum 8 - 10 years of progressive QA and RA experience within the Medical Devices sector. You will need to have strong technical knowledge across ISO 13485, GDPMDS, CAPA, post-market surveillance, MDR, supplier quality management, and design controls. Experience managing multiple manufacturing sites and supporting regional or global Sales & Marketing organisations is required. Having experience with Class II and/or Class III medical devices will be strongly preferred. Professional certifications such as ASQ CQA, CQE, or RAC will be an added advantage.

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