Regulatory Affairs Specialist (Medical Device) #HHL
Recruit Express Tampines Full-time
Location: EAST
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:
- 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
Interested applicants, please send your updated resume to ale••••@recruitexpress.com.sg
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599).
Recruit ExpressPasir Ris, 3 km from Tampines
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
Interested applicants, please send your updated resume...
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