Regulatory Affairs Executive – Medical Devices / IVD

Recruit123; Singapore; On-site; SGD 56,000 - 78,000; Full time

Job summary

Recruit123 is seeking a Regulatory Affairs Executive to support registration and compliance for medical devices and IVDs across Singapore and ASEAN. You will collaborate with cross-functional teams to keep products in market and compliant.

Responsibilities include preparing submissions to HSA, maintaining technical files, handling labeling reviews, and monitoring regulatory changes. The ideal candidate has 2–5 years in regulatory affairs and a strong eye for detail aligned with ISO 13485

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2-5 years regulatory affairs experience in medical devices/IVD.
• Knowledge of Singapore HSA regulations and AMDD advantageous.
• Experience preparing regulatory submissions for devices/IVD.
• Familiarity with ISO 13485 and quality management systems.

Responsibilities

• Prepare and submit regulatory applications to the Health Sciences Authority (HSA).
• Support product registrations, renewals, and change notifications.
• Maintain regulatory documentation and files per ISO 13485 requirements.
• Review labeling, IFU, and packaging for regulatory compliance.
• Monitor regulatory changes and impact on product portfolios.
• Coordinate with authorities and regional teams on submissions.
• Support post-market surveillance and vigilance reporting as required.
• Participate in audits and regulatory projects.
• Maintain accurate regulatory submission databases.

Skills

Attention to detail

Stakeholder management

Regulatory submissions

Education

Bachelor's degree in Life Sciences or related field

Tools

Documentation systems

Job description

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.