Regulatory Affairs Specialist

1 day ago

Singapore ALCOTECH PTE. LTD. Full time

Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences Authority (HSA) or prior experience in medical device regulatory affairs. The ideal candidate will manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy. Key Responsibilities Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel. Advise on regulatory strategy, product classification, labelling, and compliance requirements. Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets. Support post-market surveillance activities. Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes. Requirements Minimum 2-5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices. Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage. Ability in speaking both English and Chinese is a requirement. We have clients all over the world. Strong organizational and project management skills; able to handle multiple submissions simultaneously. Familiarity with Therapeutic Products License (TPL) is preferred. Work Environment Office-based role Monday - Friday, 9:00 am - 6:00 pm Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore Salary $4,100 - $5,300 monthly, based on experience Why Join Us Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines. Work closely with clients and regulatory authorities in a high-impact role. Gain exposure to ASEAN regulatory environments while building professional expertise. Join a specialist regulatory company offering career growth and professional development opportunities.

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