Senior Regulatory Affairs Specialist – Greater Asia (Medical Devices)

Location: Singapore

Employment type: Full time

Company

hirify.global is a healthcare company focused on developing and delivering medical products and solutions that help save and sustain lives.

What you will do

• Design and execute regulatory strategies for innovative medical devices across Greater Asia.
• Prepare and submit registrations, renewals, license extensions, variations, and change notifications.
• Develop project plans, monitor approval timelines, and identify and escalate regulatory risks.
• Respond to regulatory authority inquiries and provide regulatory guidance to cross-functional project teams.
• Review labeling and promotional materials for compliance with applicable requirements.
• Manage post-market surveillance, field actions, complaints, regulatory databases, audits, and documentation control in Singapore and Malaysia.

Requirements

• Degree in Pharmacy, Health Sciences, or an equivalent field.
• At least 5 years of regulatory affairs experience in medical devices.
• Mandatory experience with Class II devices and above, including registrations, license extensions, variations, and renewals.
• Strong knowledge of regulatory laws, acts, evolving requirements, and GDPMD standards.
• Project management, multitasking, prioritization, risk identification, and escalation skills.
• Excellent interpersonal, communication, and negotiation abilities, with proficiency in word processing, spreadsheets, databases, and online research.

Nice to have

• Experience with RIM systems.

Culture & Benefits

• Purpose-driven work supporting hirify.global’s mission to save and sustain lives.
• Collaborative environment focused on ownership, trust, courage, and accountability.
• Opportunities to contribute to continuous improvement, process optimization, and digitization.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.