QA/RA Quality Engineer — Regulatory & QMS Specialist

A leading company in medical devices located in Kulim, Malaysia, is seeking a Regulatory Affairs professional to ensure compliance with the organization’s regulatory and Quality Management System. Key responsibilities include managing audits, overseeing document control activities, and supporting regulatory submissions. Candidates should have a Bachelor’s Degree in Science or Engineering, with at least 1 year of manufacturing experience being preferred. Effective communication skills in English and Bahasa Malaysia are essential, while proficiency in Japanese is an advantage.
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