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.