QUALITY ASSURANCE & REGULATORY AFFAIRS

RENAL LABORATORIES SDN. BHD.; Nilai; On-site; MYR 67,000 - 112,000; Full time

Job summary

RENAL LABORATORIES SDN. BHD. is seeking a QA and Regulatory Affairs professional to support activities for medical devices and pharmaceuticals. The role includes preparing regulatory submissions for Malaysia, Taiwan FDA and ASEAN, maintaining registration records, and liaising with authorities.

The candidate will monitor ISO 13485 and GMP compliance, review SOPs and quality docs, and assist with QMS documentation. Strong coordination and attention to detail are essential.

Qualifications

• Experience or knowledge in quality assurance, regulatory affairs, medical devices, pharmaceuticals, or related field.
• Understanding of regulatory submissions, product registration, licensing, and renewal processes.
• Familiarity with ISO 13485, GMP, QMS documentation, SOPs, and quality records.

Responsibilities

• Support quality assurance and regulatory affairs activities for medical device and pharmaceutical products.
• Prepare and maintain regulatory submission documents for MDA Malaysia, Taiwan FDA, and other ASEAN countries.
• Maintain product registration records, licences, and renewal tracking.
• Liaise with regulatory authorities regarding registration and compliance matters.
• Monitor compliance with ISO 13485, GMP, and applicable regulatory requirements.
• Review SOPs, specifications, protocols, and quality documents.
• Support the implementation and maintenance of QMS documentation.
• Perform other duties assigned by the superior.

Skills

Documentation skills

Coordination

Regulatory liaison

Quality assurance

Regulatory submissions

ISO 13485

GMP

Job description

Support quality assurance and regulatory affairs activities for medical device and pharmaceutical products, helping maintain compliance, accurate regulatory records, and effective quality management systems.

Key responsibilities

Support quality assurance and regulatory affairs activities for medical device and pharmaceutical products.

Prepare and maintain regulatory submission documents for MDA Malaysia, Taiwan FDA, and other ASEAN countries.

Maintain product registration records, licences, and renewal tracking.

Liaise with regulatory authorities regarding registration and compliance matters.

Monitor compliance with ISO 13485, GMP, and applicable regulatory requirements.

Review SOPs, specifications, protocols, and quality documents.

Support the implementation and maintenance of QMS documentation.

Perform other duties assigned by the superior.

What we're looking for

Experience or knowledge in quality assurance, regulatory affairs, medical devices, pharmaceuticals, or a related field.

Understanding of regulatory submissions, product registration, licensing, and renewal processes.

Familiarity with ISO 13485, GMP, QMS documentation, SOPs, and quality records.

Strong documentation, organisational, communication, and coordination skills.

Ability to liaise effectively with regulatory authorities and internal stakeholders.

Strong attention to detail and the ability to manage multiple compliance-related activities.

Renal Laboratories is a subsidiary of the Excelsior Medical Healthcare group of Taiwan, a public listed company and the market leader in providing Dialysis Services in Taiwan, currently manages more than 150 dialysis centers with a total of 13,500 dialysis patients and 4,500 dialysis machines throughout Asia region.

Renal Laboratories (RL) began with the manufacturing facilities in 2010 located strategically in Bandar Enstek, Negeri Sembilan. RL is the manufacturer of dialysis concentrates, dialysis powders and cartridges.

The QMS of RL meets the requirements of the EN ISO 13485:2016, HALAL and MS ISO 13485:2017. RL facilitate with in-house QC Laboratory which compliance with ISO 17025.

Renal Laboratories is a subsidiary of the Excelsior Medical Healthcare group of Taiwan, a public listed company and the market leader in providing Dialysis Services in Taiwan, currently manages more than 150 dialysis centers with a total of 13,500 dialysis patients and 4,500 dialysis machines throughout Asia region.

Renal Laboratories (RL) began with the manufacturing facilities in 2010 located strategically in Bandar Enstek, Negeri Sembilan. RL is the manufacturer of dialysis concentrates, dialysis powders and cartridges.

The QMS of RL meets the requirements of the EN ISO 13485:2016, HALAL and MS ISO 13485:2017. RL facilitate with in-house QC Laboratory which compliance with ISO 17025.