MUN Global Hiring! Full Time Executive - Regulatory Affairs in Selangor - Ricebowl

OVERVIEW

• To support the Superior in regulatory, statutory, and Quality Management System (QMS) requirements matters.
• Support to develop, register, facilitate, and maintain all regulatory submissions related to establishment and product registration with applicable Regulatory Authority.
• Support and assist in liaising with regulatory authorities, designated agents, and notified bodies on all regulatory-related matters.
• Keep up to date with changes in regulatory, statutory, and QMS requirements to ensure company compliance with required changes.
• Coordinate all the QMS-related documentation systematically in compliance with the QMS requirements.
• Support to review labelling, storage, and packaging requirements in accordance with regulatory requirements to ensure compliance in product labelling.
• Participates in post-market surveillance activities by conducting routine systematic literature reviews.
• Assist in managing quality and regulatory interactions with customers and supplier, including QC inspection,
• CAPA/SCAR follow-ups, and handling customer complaints and returns.
• Assist and participates in conducting Quality Audits and drive continuous improvement efforts, through facilitating and collaborating with cross-functional and inter-department stakeholders.
• Assist in providing training in matters related to regulatory and QMS. As well as continuous improvement initiatives within RA & QMS related matter.

REQUIREMENTS

• Bachelor’s Degree in Science or equivalent.
• Work Experience:
• Minimum 2 years of experience in medical device regulatory positions or similar roles and responsibilities is preferred.
• ISO 13485 and GDPMD.
• Products testing, licensing, registration, and certification.
• Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).