Executive QA (Regulatory & Complaint Support)

Hartalega; Sepang; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading manufacturing company in Selangor, Malaysia, is seeking a Regulatory Support position responsible for ensuring compliance with statutory requirements. The role includes preparing product specifications, responding to regulatory inquiries, and managing customer complaints. Suitable candidates should have a Bachelor’s Degree in Science or Engineering and ideally some experience in a manufacturing environment. Fresh graduates are welcome to apply. This is a great opportunity to grow in regulatory affairs.

Qualifications

• Fresh graduate or 2 years of working experience in manufacturing environment.
• Medical device regulatory knowledge will be an added advantage.

Responsibilities

• Assist in preparing and managing product declarations and specifications.
• Respond to customer regulatory inquiries and maintain Technical Files.
• Log and trace customer complaints, liaise with QA for investigations.
• Prepare summary reports on complaints for management.
• Collaborate with internal teams and maintain professional communication.

Skills

Regulatory compliance

Document management

Customer communication

Complaint analysis

Education

Bachelor’s Degree in Science / Engineering

Job description

Overview

Responsible for ensuring company and manufactured products comply with regulatory and statutory requirements. Supports regulatory submissions for multiple international markets (Canada, China, Korea, EU, USA, etc.). Assists the Manager in coordinating and documenting customer complaint investigations to ensure timely resolution and compliance with internal procedures.

Responsibilities

• Document Management & Support: Assist in preparing and managing declarations (chemical, equivalency, shelf life, conformity), MSDS, technical specifications, IFUs, and product specifications (new/revised). Support questionnaires, tenders, and internal/external lab testing coordination. Review/validate labelling artwork per regulatory requirements (UDI, MDR, PPE, EU Rep). Update EU compliance records (MDSS, SATRA) and maintain 510(k), FDA FURLS, EUDAMED listings. Support global registrations for multiple markets under supervision. Coordinate review of Quality Agreements/External Product Specifications with stakeholders.
• Regulatory Compliance & Support: Respond to customer regulatory inquiries, escalating complex matters. Review SOPs/forms and assist with updates per regulatory changes. Maintain/update Technical Files for branded customers, including control list and verification certificate tracking. Support mock recall exercises, training material preparation, and internal regulatory training. Manage product specification updates and regulatory authority system entries.
• Customer Complaint Support: Log and trace customer complaints in the system. Liaise with Plant QA for investigation data and formal responses. Draft responses, follow-up documentation, and track timely closure. Analyse complaint trends within assigned plants and escalate systemic issues. Coordinate complaint investigation and CAPA processes on complex or multi-plant complaints, when needed.
• Communication & Improvement: Coordinate with internal teams (QA, R&D, Sales, Marketing) and external bodies (EU Rep, Notified Bodies). Prepare summary reports on complaints/CAPA for management. Contribute to continuous improvement and knowledge-sharing initiatives.
• People / Stakeholder Management: Collaborate with peers and cross-functional teams. Maintain professional communication with customers and stakeholders. Build positive working relationships and respond promptly to routine inquiries. Engage in training and development to strengthen regulatory/quality knowledge.

Qualifications

• Education: Bachelor’s Degree in Science / Engineering or any related field.
• Work Experience: Fresh graduate or 2 years of working experience in manufacturing environment.
• Technical and Professional Knowledge: Medical device regulatory knowledge will be an added advantage.