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