QA/RA Specialist

1 week ago

Singapore MCI CAREER SERVICES PTE. LTD. Full time

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)

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