Senior Quality Compliance Specialist

3 days ago

Singapore beBeeRegulatory Full time

Job Description

We are seeking a highly skilled Quality Assurance and Regulatory Affairs Specialist to join our team. As a key member, you will play a crucial role in ensuring compliance with regulatory requirements, product registrations, audits, and maintaining our Quality Management System (QMS).

About the Role

This is an exciting opportunity for a detail-oriented and proactive professional to support Quality Assurance and Regulatory Affairs functions. You will work closely with our team to implement and maintain QMS in compliance with ISO13485, cGMP, and international regulatory requirements.

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, 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.

Benefits

We offer a stable career with growth opportunities in QA/RA, exposure to international quality and regulatory frameworks, and a variable bonus package.

What We Offer

Join us and take advantage of this exciting opportunity to develop your skills and advance your career in Quality Assurance and Regulatory Affairs.

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