Senior Regulatory & QA Lead, Medical Devices

Terumo; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

Terumo in Malaysia is seeking a Regulatory Affairs and Quality Assurance professional to manage registration of medical device products in Malaysia and Singapore, and to oversee submissions, labeling updates, and regulatory reporting across emerging markets.

You will uphold QMS (GDPMD, GDP) and support internal/external audits, CAPA, and cross-functional governance, guiding junior RA/QA members and coordinating with authorities such as MDA, SIRIM, and NPRA.

Qualifications

• Bachelor’s degree or diploma in pharmacy, medical science or related studies
• Minimum 3 years of regulatory affairs & quality assurance experience in medical device/pharmaceutical/healthcare industry or related fields

Responsibilities

• Maintain registration of medical device products in Malaysia
• Involve with registration dossier preparation & submission, follow ups, monitoring and obtain approval
• Post-market surveillance including handling complaints and reporting to authorities
• Maintain and improve the Quality Management System (GDPMD) and ISO 13485 compliance
• Support internal and external audits, CAPA, deviations, and change control
• Liaise with authorities (MDA, SIRIM, NPRA, etc) for registrations and regulatory updates
• Provide governance and mentoring for RA/QA team and participate in management reviews

Skills

Regulatory knowledge

Attention to detail

Auditing experience

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree or diploma in pharmacy, medical science or related studies

Job description

Terumo in Malaysia is seeking a Regulatory Affairs and Quality Assurance professional to manage registration of medical device products in Malaysia and Singapore, and to oversee submissions, labeling updates, and regulatory reporting across emerging markets.

You will uphold QMS (GDPMD, GDP) and support internal/external audits, CAPA, and cross-functional governance, guiding junior RA/QA members and coordinating with authorities such as MDA, SIRIM, and NPRA.