Senior Regulatory Affairs Lead, Medical Devices & QMS

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

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.