Regulatory Affairs Specialist in Regulatory Compliance and Quality Management Thermo Fisher Scientific in Malaysia

Thermo Fisher Scientific is seeking a Regulatory Affairs & Quality Compliance Specialist to join their team in Selangor, Malaysia. This hybrid position focuses on ensuring compliance with Malaysian Medical Device Authority (MDA) regulations and Chemical Compliance requirements. The successful candidate will act as the primary liaison for Fisher Scientific (M) Sdn Bhd and its affiliates, maintaining the Establishment License, managing GDPMD product registrations, conducting chemical screening, and overseeing chemical permit applications. Responsibilities also include ensuring adherence to the Medical Device Act, Poison Act, Dangerous Drugs Act, and other relevant Malaysian regulations.

The role supports and manages the Site Quality Management System (QMS) through audits, SOP control, documentation integrity, risk management, and Post Market Surveillance activities. Candidates should have a degree in Science, Regulatory Affairs, Biomedical, Chemistry, or a related field, with experience in Medical Device Regulation (MDA), GDPMD, and/or Chemical Compliance preferred. Strong regulatory documentation skills, QMS process knowledge, audit readiness, and excellent interpersonal skills are essential.

This opportunity is ideal for individuals interested in regulatory affairs, quality compliance, and the intersection of biomedical and chemical sciences within a leading scientific company. Interested applicants should send their resume to [email protected] for referral consideration. For more information, visit the LinkedIn profile provided.