Quality & Regulatory Affairs Executive (Life Science)

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 30,000 - 45,000; Full time

Job summary

An established company in Biomedical and Manufacturing in Singapore is looking for a Quality & Regulatory Affairs Executive. The role will support QMS compliance with various regulatory standards and involve responsibilities from QA strategy development to liaising with regulatory bodies. Candidates with a Diploma in Life Science and willing to learn are encouraged to apply. Training will be provided, and only shortlisted candidates will be contacted.

Qualifications

• 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.

Responsibilities

• Support the implementation and maintenance of the QMS in compliance with regulatory standards.
• Assist in QA strategy development, product registration, renewals, and regulatory submissions.
• Coordinate with representatives to stay updated on regulatory changes.
• Provide support for QMS functions including document control, audits, and training.
• Act as an independent reviewer for validation protocols.
• Liaise with regulatory bodies, customers, and auditors.
• Communicate regulatory changes and support their implementation.

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: [e-mail]
• EA License No: 19C9682
  EA Personnel No: R2198636
  EA Personnel Name: Oh Puey Xin