Specialist, Regulatory Affairs

Key Purpose Support regulatory affairs activities across Singapore and Asia Pacific, including product registrations, license maintenance, regulatory submissions, and post-market reporting, to ensure compliance with applicable medical device regulations and timely market access.

Key Responsibilities

Prepare and submit product registration applications, renewals, amendments, and regulatory licenses to local regulatory authorities. Maintain product registrations, licenses, and regulatory databases to ensure ongoing compliance. Support adverse event (AE) reporting, Field Safety Corrective Actions (FSCA), and other post-market regulatory activities.

Coordinate with manufacturers, affiliates, distributors, and internal stakeholders to obtain regulatory documentation and support submissions. Monitor regulatory changes and provide regulatory guidance to internal teams, affiliates, and distributors. Support regulatory strategy development and product registration activities across the Asia Pacific region.

Maintain regulatory records, documentation, and compliance tracking systems. Support Sales, Marketing, Supply Chain, and business partners on regulatory-related matters.

Requirements

Bachelor's Degree in Medical Science, Life Sciences, Pharmacy, Biomedical Science, or a related discipline. Minimum 3 years of Regulatory Affairs experience within the medical device, IVD, or healthcare industry. Knowledge of Singapore medical device regulations and regulatory frameworks across the Asia Pacific region.

Experience in product registration, license maintenance, renewals, amendments, and post-market regulatory activities. Familiarity with adverse event reporting, FSCA, and regulatory compliance requirements. Proficient in Microsoft Office applications and standard business software. Strong organizational, communication, stakeholder management, and documentation skills.

Customer-oriented, adaptable, and able to manage multiple priorities in a dynamic environment.