Quality and Regulatory Affairs Executive (ISO13485) - Bukit Batok

Our client is an established company specialising in Biomedical and Manufacturing. They are expanding and growing at a fast pace and now looking to hire a Quality & Regulatory Affairs Executive to support the growth. They are located in the West – easily accessible.

The Responsible of Quality & Regulatory Affairs Executive will include:

• Support the implementation and maintenance of the QMS in compliance with ISO13485, FDA, EU MDR, cGMP, and other regulatory standards.
• Assist in QA strategy development, product registration, renewals, and regulatory submissions across global markets.
• Coordinate with market representatives to stay updated on regulatory changes and integrate them into the QMS.
• Provide support for QMS functions including document control, audits, CAPA, complaints, training, and recalls.
• Act as an independent reviewer for validation protocols and ensure technical documentation is maintained and submission-ready.
• Liaise with regulatory bodies, customers, and auditors, and assist with inspection readiness and post-market surveillance.
• Communicate regulatory changes and support their implementation across teams.

Requirements:

• Minimum Diploma in Life Science or related field
• Possesses at least internship experience in QA/RA
• Knowledge or experience with ISO 13485 is an added advantage

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2198636
• EA Personnel Name: Oh Puey Xin