Regulatory Affairs Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary

The Regulatory Affairs & Quality Compliance Specialist serves as the primary liaison for Fisher Scientific (M) Sdn Bhd (FSM) and its affiliated companies to ensure compliance with Malaysian Medical Device Authority (MDA) regulations and Chemical Compliance requirements. This includes maintaining the Establishment License, managing GDPMD product registrations, conducting Chemical Screening, overseeing chemical permit applications, and ensuring adherence to all relevant laws under the Medical Device Act, Poison Act, Dangerous Drugs Act, and applicable Malaysian regulations.
The role also supports and manages the Site Quality Management System (QMS) through audits, SOP control, documentation integrity, risk management, and Post Market Surveillance activities.

Key Responsibilities

Regulatory Affairs – Medical Device

• Maintain Establishment License and ensure compliance with MDA regulations, Orders, and Circulars.

• Lead Medical Device product registrations (GDPMD) via MDA e-portal and handle amendments, grouping, classification, and submission follow-ups.

• Liaise with Thermo Fisher business units, third-party vendors, and MDA officers to secure timely submission approvals.

• Provide weekly and monthly updates on registration progress to management teams.

Chemical Compliance & Screening

• Conduct Chemical Screening to ensure correct classification and regulatory compliance for distributed products.

• Lead chemical permit applications (KKM Import Permit, Vet Permit, Psychotropic Substances Permit, etc.) and act as the primary contact for all chemical compliance matters.

• Ensure chemical compliance processes meet Malaysian regulatory requirements and provide related training to internal teams.

Quality Management System (QMS)

• Handle Site QMS activities including audits, documentation review, complaints, investigations, Post Market Surveillance, and risk management.

• Prepare the site for regulatory audits and work with workstream owners to maintain accurate and valid Working Instructions (WIs).

• Collaborate with RSD Singapore on shared processes such as Global Trade Compliance (GTC) SOPs.

Documentation & SOP Management

• Establish, review, and maintain SOPs for Medical Device registration, chemical compliance, and QMS processes.

• Ensure all documentation is accurate, complete, and audit-ready.

Cross-Functional Support

• Support Product Management, Commercial, Supply Chain, and other functional teams with regulatory guidance.

• Provide backup support to RSD Singapore when required.

Qualifications

• Degree in Science, Regulatory Affairs, Biomedical, Chemistry, or a related field.

• Experience in Medical Device Regulation (MDA), GDPMD, and/or Chemical Compliance preferred.

• Strong understanding of regulatory documentation, QMS processes, and audit readiness.

• Excellent interpersonal skills and attention to detail.