Senior Regulatory Affairs Specialist (Med Device)

Location: Loyang

Salary: Up to $6,000

Working Hours: Mon – Fri, Office Hours

Responsibilities:

• Handle regulatory submissions for medical devices (US FDA, EU MDR, ASEAN, etc.)
• Prepare and maintain product registrations, renewals, and variations
• Support regulatory strategy for product launches and change implementations
• Ensure compliance with FDA, ISO 13485, MDR, and global regulatory requirements
• Support MDR/Vigilance reporting and field safety actions when required

Requirements:

• Min. Degree in Life Sciences, Pharmacy, Biomedical Science or related field
• Min. 4 years regulatory affairs experience in medical devices
• Hands-on experience with US FDA submissions is required
• Familiar with ISO 13485 and medical device regulations

If interested, please email me at ***email_hidden*** or telegram @alexgohhl

Alex Goh Hock Leong

(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599).