QA/RA Specialist

9 hours ago

Singapore MCI CAREER SERVICES PTE. LTD. Full time
Roles & Responsibilities

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 (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: R

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

Tell employers what skills you have
CAPA
FDA
Quality Management
Quality Assurance
Regulatory Affairs
TGA
Chemistry
Surveillance
Biology
Employee Benefits
Audits
Regulatory Requirements
Life Sciences
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