Lead Quality Assurance and Regulatory Affairs Specialist

2 weeks ago

Singapore beBeeCompliance Full time $90,000 - $120,000

Senior Quality Assurance and Regulatory Affairs Professional


Job Description

The ideal candidate for this role will have a strong background in quality assurance and regulatory affairs, with experience in implementing and maintaining quality management systems. They will be responsible for ensuring compliance with international regulatory requirements, as well as supporting product registrations, audits, and training programs.

  • Implement and maintain a quality management system (QMS) in accordance with ISO13485, FDA 21 CFR, EU MDR, and other applicable regulations.
  • Support document control, management reviews, audits (internal & external), corrective action plans (CAPA), product complaints, and training programs.
  • Act as an 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 Responsibilities
  • 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 the 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.
Required Skills and Qualifications
  • 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
  • A stable career with growth opportunities in QA/RA.
  • Exposure to international quality and regulatory frameworks.
  • Variable bonus and employee benefits.

This is a challenging opportunity for a seasoned professional looking to take on a leadership role in quality assurance and regulatory affairs. The ideal candidate will have a strong understanding of quality management systems and regulatory requirements, as well as excellent communication and project management skills. If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity.

Key responsibilities include:

  • Quality Management Systems
  • Regulatory Compliance
  • Product Registrations
  • Audits and Training Programs

Requirements include:

  • Engineering or Life Sciences Degree
  • Relevant Experience
  • Knowledge of International Regulations
  • Excellent Communication and Project Management Skills

This is a challenging opportunity for a seasoned professional looking to take on a leadership role in quality assurance and regulatory affairs.

About the Role

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
  • Regulatory Submissions

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