Job Description

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:

Minimum Diploma in Life Science or related field Entry level are welcome to apply. Training provided Knowledge or experience with ISO 13485 is an added advantage
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.

Email Address: jobs@recruitpedia.sg

EA License No: 19C9682

EA Personnel No: R2198636


EA Personnel Name: Oh Puey Xin