Regulatory Affairs Executive – Medical Devices / IVD

RECRUIT123 PTE. LTD.; Singapore; Presencial; SGD 56.000 - 78.000; Tempo integral

Resumo da vaga

RECRUIT123 PTE. LTD. is seeking a Regulatory Affairs Executive to support registrations for medical devices and IVDs in Singapore and ASEAN. The role focuses on ensuring compliance, maintaining registration records, and collaborating with cross-functional teams to bring compliant products to market.

You will prepare submissions to HSA, manage document control, and monitor regulatory changes. The ideal candidate has 2–5 years in regulatory affairs and a solid understanding of ISO 13485.

Qualificações

• Bachelor's Degree in Life Sciences or related discipline.
• 2–5 years of regulatory affairs experience in medical devices/IVD/diagnostics/healthcare.
• Working knowledge of Singapore HSA medical device regulations and registration requirements.
• Familiarity with ASEAN Medical Device Directive (AMDD) and regional regulatory frameworks is advantageous.
• Understanding of ISO 13485 and quality management systems.
• Experience preparing regulatory submissions and managing product registrations.
• Strong attention to detail with excellent documentation and stakeholder management.
• Ability to work independently while managing multiple projects and deadlines.

Responsabilidades

• Prepare, compile, and submit regulatory applications for medical devices and IVD products to HSA.
• Support product registrations, renewals, change notifications, and regulatory maintenance activities.
• Maintain technical documentation and regulatory files per regulations and ISO 13485.
• Review product labelling, instructions for use, and packaging for compliance.
• Monitor regulatory changes and assess business impact across portfolios.
• Liaise with authorities, regional regulatory teams, manufacturers, and stakeholders on submissions.
• Support post-market surveillance, vigilance reporting, and compliance initiatives.
• Participate in audits, inspections, quality management activities, and regulatory projects.
• Maintain accurate regulatory records and submission databases.

Conhecimentos

Attention to detail

Documentation

Stakeholder management

Project management

Independent working

Formação

Bachelor's Degree in Life Sciences

Descrição da vaga

Regulatory Affairs Executive – Medical Devices / IVD

Salary: S$5,000 – S$7,000 per month
Location: Singapore

About the Role

Our clients are leading medical device, diagnostics, and life sciences organizations seeking Regulatory Affairs Executives to support product registrations and regulatory compliance activities across Singapore and the wider ASEAN region.

This role is ideal for regulatory professionals who enjoy navigating evolving healthcare regulations, managing submissions, and partnering with cross-functional teams to bring compliant medical technologies to market.

Key Responsibilities

• Prepare, compile, and submit regulatory applications for medical devices and IVD products to the Health Sciences Authority (HSA).
• Support product registrations, renewals, change notifications, and regulatory maintenance activities.
• Maintain technical documentation and regulatory files in accordance with applicable regulations and ISO 13485 requirements.
• Review product labelling, instructions for use, promotional materials, and packaging to ensure regulatory compliance.
• Monitor regulatory changes and assess business impact across product portfolios.
• Liaise with local authorities, regional regulatory teams, manufacturers, and internal stakeholders on submission requirements and approval processes.
• Support post-market surveillance activities, field safety corrective actions, vigilance reporting, and compliance initiatives where required.
• Participate in audits, inspections, quality management activities, and regulatory projects.
• Maintain accurate regulatory records and submission databases.

Requirements

• Bachelor's Degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs, Biotechnology, or a related discipline.
• 2–5 years of regulatory affairs experience within medical devices, IVD, diagnostics, or healthcare-related industries.
• Working knowledge of Singapore HSA medical device regulations and registration requirements.
• Familiarity with ASEAN Medical Device Directive (AMDD) and regional regulatory frameworks is advantageous.
• Understanding of ISO 13485 and quality management systems.
• Experience preparing regulatory submissions and managing product registrations.
• Strong attention to detail with excellent documentation and stakeholder management skills.
• Ability to work independently while managing multiple projects and deadlines.

Preferred Experience

• Medical Devices
• In Vitro Diagnostics (IVD)
• Diagnostic Equipment
• Surgical Devices
• Wound Care Products
• Healthcare Technologies
• Life Sciences Products

What Success Looks Like

You are able to navigate regulatory pathways confidently, maintain compliant product registrations, manage documentation effectively, and work collaboratively with commercial, quality, and technical teams to ensure products remain available to healthcare providers and patients.