QA/RA Specialist (Medical Device / Pharma)

MCI CAREER SERVICES PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A recruitment agency is seeking a QA/RA Specialist to ensure compliance with regulatory requirements and manage the company’s Quality Management System. The ideal candidate will have a degree in Engineering or Life Sciences and a keen understanding of ISO13485 and cGMP. Successful applicants will enjoy a stable career path with opportunities for growth in QA/RA, exposure to international standards, and competitive remuneration with a variable bonus.

Benefits

Stable career with growth opportunities

Variable bonus and employee benefits

Qualifications

• Strong knowledge of ISO13485, cGMP, and international regulatory frameworks.
• Ability to manage and maintain Quality Management Systems.
• Experience in product registrations and regulatory submissions.

Responsibilities

• Implement and maintain Quality Management Systems in compliance with regulations.
• Support document controls, audits, and training.
• Assist with product registrations and liaising with regulatory bodies.

Skills

Detail-oriented

Proactive

Independent work capability

Education

Degree in Engineering (Mechanical) or Life Sciences

Diploma with 3+ years of relevant experience

Job description

Job Highlight

• Location : Tuas Crescent MRT
• Salary: Up to S$3,200 + Variable Bonus
• Working Hours: 7.45 a.m. – 4.45 p.m. (Monday – Friday)

About the Role
Our client is looking for a motivated QA/RA Specialist to join our team. In this role, you will support Quality Assurance and Regulatory Affairs functions, ensuring compliance with ISO13485, cGMP, and international regulatory requirements. You will also play a key role in product registrations, audits, and maintaining the company’s Quality Management System (QMS).

Key Responsibilities

Quality Assurance (QA)

• Implement and maintain QMS in compliance with ISO13485, FDA 21 CFR, EU MDR, and other applicable regulations.
• Support document control, management reviews, audits (internal & external), CAPA, product complaints, and training.
• Act as independent reviewer for validation protocols (IQ/OQ/PQ) and reports.
• Communicate regulatory or quality requirement changes to relevant departments and ensure timely implementation.

Regulatory Affairs (RA)

• Assist with product registration, renewal, and change notifications across global markets.
• Liaise with regulatory agencies, consultants, and authorized representatives to track and incorporate updated requirements into QMS.
• Prepare and maintain dossiers and technical documents for regulatory submissions.
• Maintain and update a listing of registered products and manage renewals.
• Support post-market surveillance, recalls, and audit preparation with customers and regulatory bodies.

Requirements

• Degree in Engineering (Mechanical) or Life Sciences (Pharmacy, Biology, Chemistry).
• Diploma holders with 3+ years of relevant experience will be considered.
• Knowledge of ISO13485, cGMP, and international regulatory frameworks (HSA, FDA, TGA, NMPA, EU MDR).
• Detail-oriented, proactive, and able to work independently.

What We Offer
Stable career with growth opportunities in QA/RA
Exposure to international quality and regulatory frameworks
Variable bonus and employee benefits

Interested candidate may submit full resume to 6990 0434 (WhatsApp - Miya) and only shortlisted candidate will be notified.

By submitting your personal data and/or resume, you give consent to collection, use and disclosure of your personal data and/or resume by the company (or its agent) for the purpose of the processing and administration by the company relating to this job application.

Kuan Mei Yang

Registration Number: R24124509

EA License No: 06C2859 (MCI Career Services Pte Ltd)