Regulatory Affairs Specialist
1 day 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 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
4 days ago
Central Singapore Emprego SG Full time**Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $5,000 - $10,000 Per Month **Date Posted** 6 minutes ago Additional Details **Job ID** 3010 **Job Views** 1 Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting multiple...
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Regulatory Affairs Specialist
6 days ago
Singapore Agilent Technologies, Inc. Full timeAs a Regulatory Affairs Specialist, you will develop and implement programs and processes and provide support to ensure that Agilent products are safe, legal, and meet or exceed customer expectations and quality in compliance with regulations, standards, company policies, and business objectives. You will perform activities which include: - Keeps abreast...
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Regulatory Affairs Specialist, Asean
21 hours ago
Singapore DN & Associates Executive Search Full timeOur client is a global medical device company and leader in new product development and medical education. They are pioneers in their speciality and every year, develop over a thousand innovative and specialised surgical products. Their mission is simple; to better the lives of the millions of patients using their products worldwide. They are looking for a...
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Regulatory Affairs Specialist, Asean
21 hours ago
Singapore DN & ASSOCIATES EXECUTIVE SEARCH PTE. LTD. Full timeOur client is a global medical device company and leader in new product development and medical education. They are pioneers in their speciality and every year, develop over a thousand innovative and specialised surgical products. Their mission is simple; to better the lives of the millions of patients using their products worldwide. They are looking for a...
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Regulatory Affairs Specialist
5 days ago
Central Singapore L'Oréal Full time $60,000 - $80,000 per yearGENERAL DESCRIPTIONYou will be based in Singapore and be part of the Scientific & Technical Regulatory Affairs Department of the L'Oreal Malaysia & Singapore cluster organization.As a Regulatory Affairs Specialist, you will work with internal and external stakeholders to ensure that the company meets the relevant regulatory requirements, secure our license...
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Singapore Penumbra, Inc. Full timeA global healthcare company is seeking a Regulatory Affairs Specialist in Singapore. This role involves preparing regulatory submissions and ensuring compliance with medical device regulations. The ideal candidate has a Bachelor's degree and over 3 years of experience in regulatory affairs within the medical device industry. Proficiency in MS Office and...
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Singapore JNPMEDI Inc. Full timeA leading medical technology company in Singapore is seeking a Regulatory Affairs Specialist to manage product submissions and regulatory filings. The ideal candidate will have over 5 years of experience in regulatory affairs within the medical device sector, strong communication skills, and the ability to work across diverse teams. The role involves...
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Regulatory Affairs Specialist
6 days ago
Singapore Boston Scientific Corporation Full time**Work mode**:Hybrid**Onsite Location(s)**:Singapore, 01, SG**Summary** Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation. Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any...
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Regulatory Affairs Specialist
3 days 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...
