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

About the Company

This position is with a well-established Japanese multinational corporation specializing in Medical Devices, with extensive operations across various Asian markets and strong connections to its global headquarters. The company is renowned for its commitment to advancing solutions for hospital and chronic care by blending profound clinical knowledge with sustained investment in innovation, integrated care models, and digital technologies.

Role Overview

We are seeking an Assistant Manager to join the Quality Assurance and Regulatory Affairs team in Singapore as part of the company’s regional growth strategy. Reporting directly to the QA/RA Manager, the successful candidate will handle various critical functions including complaint management, GDPMDS audits, change control processes, and staff training coordination within the region.

Key Responsibilities

• Oversee complaint investigations to assess reportability and manage the reporting of Field Safety Corrective Actions and adverse events to relevant regulatory bodies.
• Lead product registration efforts and ensure timely market access approvals in assigned countries by collaborating closely with headquarters and original equipment manufacturers to compile and submit all necessary documentation.
• Review and authorize post-market change notifications, including labelling revisions.
• Maintain ongoing liaison with local regulatory authorities to ensure compliance.
• Serve as the company’s Management Representative, ensuring adherence to international regulatory standards and internal policies.

Qualifications and Experience

• Minimum of five years’ practical experience in Quality Assurance and Regulatory Affairs within the Medical Devices sector.
• Strong understanding of GDPMDS standards, Health Sciences Authority (HSA) regulations, and ASEAN regional medical device registration guidelines.
• Proven capability in managing product registrations, conducting post-market surveillance, and handling FSCA reporting.
• Excellent communication and organizational skills enabling independent handling of multiple tasks and interaction with both regional teams and global headquarters.

Compensation and Benefits

• Competitive base monthly salary up to SGD 7,500.
• Additional allowances including Annual Wage Supplement (AWS) and Variable Bonus (VB).

Additional Information

This role involves significant regional coordination and regulatory interaction, making it an excellent opportunity for candidates looking to advance their career in a multinational environment with a strong focus on compliance and quality management within the medical device industry.