QA RA Specialist (ISO13485)

RecruitPedia Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biomedical and manufacturing company located in the West of Singapore is seeking a Quality & Regulatory Affairs Executive. In this role, you will support the implementation of the QMS in compliance with various regulatory standards and assist in QA strategy development. Ideal candidates should have a diploma in Life Science and at least one year of relevant experience. Interested applicants should send their resume to our recruitment email.

Qualifications

• Minimum Diploma in Life Science or related field.
• Min 1 year of QA or RA experience in medical devices.
• Knowledge of 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, and regulatory submissions.
• Coordinate with representatives to stay updated on regulatory changes.

Skills

Quality Assurance

Regulatory Affairs

Document Control

Education

Diploma in Life Science or related field

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 Responsibilities 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
• Min 1 year of QA or RA experience in medical devices
• 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 to [e-mail]. We regret that only shortlisted candidates will be notified.

Equal Employment Opportunity Statement: Our company is an equal opportunities employer.