Regulatory Affairs Executive, Medical Devices & IVD (ASEAN)

Recruit123; Singapore; Presencial; SGD 56.000 - 78.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Attention to detail

Stakeholder management

Regulatory submissions

Educación

Bachelor's degree in Life Sciences or related field

Herramientas

Documentation systems

Descripción del empleo

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