Regulatory Affairs Specialist
9 hours ago
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. #J-18808-Ljbffr
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Regulatory Affairs Specialist
1 week ago
Singapore Johnson & Johnson Full timeJohnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...
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Regulatory Affairs Specialist
2 weeks ago
Singapore Johnson & Johnson Full timeThe Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...
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Regulatory Affairs Specialist
9 hours ago
Singapore Reeracoen Singapore Pte Ltd Full timeOverview Job title: Regulatory Affairs Specialist. Reference ID: 36639. Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and...
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Regulatory Affairs Specialist
4 weeks ago
Singapore ALCOTECH PTE. LTD. Full timeAlcotech 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...
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Regulatory Affairs Specialist
2 weeks ago
Singapore ALCOTECH PTE. LTD. Full time $49,300 - $63,500 per yearAlcotech 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 OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...
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Specialist, Regulatory Affairs
9 hours ago
Singapore ResMed (Malaysia) Sdn Bhd (MY) Full timeAbout ResMed At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and...
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Regional Regulatory Affairs Specialist
2 days ago
Singapore Reeracoen Singapore Pte Ltd Full timeJob title: Regional Regulatory Affairs Specialist Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring...
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Surveillance Regulatory Affairs Officer
2 days ago
Singapore Marina Bay Sands Full timeJoin to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HERE!Be part of our diverse and...
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Surveillance Regulatory Affairs Officer
4 weeks ago
Singapore Marina Bay Sands Full timeJoin to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HEREBe part of our diverse and...
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Quality and Regulatory Affairs Specialist
6 days ago
Singapore Majeton Pte. Ltd. Full timeOverview At Majeton, we are driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality & Regulatory...
