Executive - Regulatory Affairs

MUN Global; Batu Caves; On-site; MYR 60,000 - 80,000; Full time

Job summary

A regulatory and quality management company is looking for a professional to support compliance with regulatory and Quality Management System (QMS) requirements. This role involves coordinating documentation, liaising with authorities, and participating in audits. Ideal candidates should hold a Bachelor's Degree in Science and have at least 2 years of experience in medical device regulatory roles. Knowledge of ISO 13485 is essential, along with skills in CAPA and RCA.

Qualifications

• Minimum 2 years of experience in medical device regulatory positions or similar roles is preferred.
• Knowledge of ISO 13485 and GDPMD standards.
• Experience in product testing, licensing, registration, and certification.

Responsibilities

• Support regulatory and QMS requirements.
• Coordinate QMS-related documentation.
• Liaise with regulatory authorities and stakeholders.
• Conduct routine literature reviews for post-market surveillance.
• Manage quality interactions with customers and suppliers.

Skills

Regulatory compliance

Quality Management System (QMS)

Corrective Action and Preventive Action (CAPA)

Root Cause Analysis (RCA)

Education

Bachelor’s Degree in Science or equivalent

Job description

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).