Quality & Regulatory Affairs Executive (Life Science)

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 Responsibles 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 :

Interested candidates who wish to apply for the advertised position, please email an updated copy of your resume / cv.

We regret that only shortlisted candidate will be notified.

EA Personnel No : R2198636

EA Personnel Name : Oh Puey Xin

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