APAC Regulatory & Quality Assurance Specialist

Applied Medical Corporation; Singapore; Vor Ort; SGD 40.000 - 64.000; Vollzeit

Benefits dieser Stelle

Benefits package under local labor law

Zusammenfassung

Applied Medical is seeking a Regulatory Affairs & Quality Assurance (RAQA) Specialist to support regulatory compliance and QMS activities across APAC. The role ensures medical devices are registered, distributed, and maintained per ISO 13485 and local regulations, serving as a liaison between regional teams, global RAQA, distributors, and authorities.

The position involves change management, license renewals, post-market activities, and audits to maintain business continuity and product safety

Qualifikationen

• Bachelor’s degree in engineering, physical or biological sciences, regulatory or related technical discipline.
• GDPMDS training or equivalent quality systems training.
• 1–2 years of experience in regulatory affairs and/or quality assurance for medical devices.

Aufgaben

• Obtain APAC product registrations following regulatory plan and local regulations.
• Perform regulatory assessments for product changes and labeling updates.
• Manage license renewals to ensure business continuity.
• Support post-market activities including AE/FSCA reporting and recalls if required.
• Participate in internal and external audits and maintain quality records.

Kenntnisse

Independent worker

Analytical

Attention to detail

Communication skills

Ausbildung

Bachelor’s in Engineering/Science

GDPMDS quality systems training

Jobbeschreibung

Applied Medical is seeking a Regulatory Affairs & Quality Assurance (RAQA) Specialist to support regulatory compliance and QMS activities across APAC. The role ensures medical devices are registered, distributed, and maintained per ISO 13485 and local regulations, serving as a liaison between regional teams, global RAQA, distributors, and authorities.

The position involves change management, license renewals, post-market activities, and audits to maintain business continuity and product safety