Senior Regulatory & QA Specialist – Medical Devices

Terumo Malaysia Sdn Bhd; Selangor; On-site; MYR 45,000 - 70,000; Full time

Job summary

Terumo Malaysia Sdn Bhd is hiring for a role focused on Regulatory Affairs and Quality Assurance, ensuring compliance with local and international standards. Candidates should have at least 3 years of experience in regulatory affairs or quality assurance in the medical device industry.

The position involves maintaining product registration, managing the Quality Management System, and collaborating across departments to meet compliance and quality standards while mentoring junior team members.

Qualifications

• Minimum 3 years of regulatory affairs & quality assurance experience in the medical device, pharmaceutical, or healthcare industry.
• Knowledge of relevant regulations like the Medical Device Act 2012 and EU Medical Device Regulation.
• Experience with internal and external auditing processes.

Responsibilities

• Manage registration of medical device products in Malaysia.
• Ensure compliance with local and international regulatory requirements.
• Maintain and improve the Quality Management System (QMS).
• Handle product complaints and reporting to authorities for adverse events.
• Provide coaching to junior RA/QA team members.

Skills

Detail-oriented

Excellent communication

Strong organizational skills

Knowledge of GDP-MMD

ISO13485

Medical Device Regulations knowledge

Education

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

Job description

Terumo Malaysia Sdn Bhd is hiring for a role focused on Regulatory Affairs and Quality Assurance, ensuring compliance with local and international standards. Candidates should have at least 3 years of experience in regulatory affairs or quality assurance in the medical device industry.

The position involves maintaining product registration, managing the Quality Management System, and collaborating across departments to meet compliance and quality standards while mentoring junior team members.