regulatory affairs manager, apac – medical devices.

About the Team | Manager
Based at the APAC regional hub in Singapore, you will report directly to the Regional Sales Manager and collaborate closely with senior regulatory and quality leadership based in the United States. Operating within a lean, high-autonomy regional structure, this position serves as the core technical and compliance authority for APAC, overseeing regulatory filings across direct markets as well as managing third-party registration partners across indirect distribution networks.

About the Job
As the Regulatory Affairs Manager, you will be responsible for ensuring the attainment of regional sales objectives by maximizing the effectiveness, skills, and productivity of the field sales team. This is a highly collaborative, people-focused leadership role divided into three key strategic focuses: conducting regularly scheduled field visits to coach, motivate, and appraise regional commercial partners and distributor regulatory leads on compliant submission strategies; analyzing complex sales data to interpret market trends, identify new business opportunities, and optimize territory targets; and managing cross-functional initiatives while overseeing regional Quality Management Systems (GDPMDS), audit readiness, and post-market compliance frameworks. Additionally, you will take direct hands-on ownership of product registrations and lifecycle submissions with the Health Sciences Authority (HSA) in Singapore, manage third-party regulatory consultants across indirect emerging markets, coordinate vigilance and Field Safety Corrective Actions (FSCA), and facilitate technical dossier alignments with US corporate headquarters.

Skills and Experience Required

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or a related scientific discipline
• 4-6 years of hands-on regulatory affairs experience within the medical device sector.
• Strong technical understanding of cardiovascular implants, tissue-based devices, biomaterials, or complex Class III medical devices. Backgrounds from companies handling device biologics, implantable grafts, or tissue processing are highly regarded.
• Proven track record handling Singapore HSA registrations firsthand, alongside familiarity with regional frameworks.
• Experience managing submissions through third-party regulatory consultants across distributor territories.
• Proven experience managing Good Distribution Practice for Medical Devices (GDPMDS) and serving as a Management Representative.
• Direct experience participating in internal and external QMS audits (familiarity with ISO 13485, MDSAP, and EU MDR technical standards is advantageous).
• Strong cross-border stakeholder management skills, comfortable liaising with global teams across US time zones when required.

To apply online, please use the 'apply' function. You may contact Putra Nur Afiq (EA: 94C3609/R22105891) directly via email or LinkedIn for a confidential discussion. We regret to inform you that only shortlisted candidates will be notified.