QA and RA Specialist (ISO13485)

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 30,000 - 40,000; Full time

Job summary

A growing Biomedical and Manufacturing company in Singapore is seeking a Quality & Regulatory Affairs Executive to support compliance with ISO standards and regulatory submissions. The position is suited for entry-level candidates, as training will be provided. Applicants with a Diploma in Life Science or related fields are encouraged to apply. Interested candidates should send their resumes to the provided email address.

Qualifications

• Entry level candidates are welcome to apply.
• Training will be provided to suitable candidates.

Responsibilities

• Support the implementation and maintenance of the QMS in compliance with standards.
• Assist in QA strategy development and regulatory submissions.
• Act as an independent reviewer for validation protocols.

Skills

Knowledge of ISO 13485

Regulatory submission support

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 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]