Senior Quality Assurance and Regulatory Affairs Professional

2 weeks ago

Singapore beBeeRegulatoryAffairs Full time
Job Summary
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.
Key Responsibilities
  • 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.
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
  • A stable career with growth opportunities in QA/RA.
  • Exposure to international quality and regulatory frameworks.
  • Variable bonus and employee benefits.
About the Role
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.
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

  • Senior Quality Assurance and Regulatory Affairs Professional

    2 weeks ago

    Singapore beBeeRegulatoryAffairs Full time $3,200

    Job SummaryThe 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...

  • Lead Quality Assurance and Regulatory Affairs Specialist

    2 weeks ago

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

    Senior Quality Assurance and Regulatory Affairs ProfessionalJob DescriptionThe 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...

  • Quality Assurance

    2 weeks ago

    Singapore VIVO SURGICAL PRIVATE LIMITED Full time

    **About Us** Our technologies redefine healthcare accessibility, allowing for widespread adoption of such modalities to improve patient outcomes. These encompass such fields as _in vivo _surgical LED lighting, portable endoscopy and mínimally-invasive robotic surgery, which are strategically co-developed with leading healthcare institutions and KOL...

  • Regulatory Affairs

    3 days ago

    Singapore RESPIREE PTE. LTD. Full time

    **Regulatory Affairs and Quality Assurance Intern** We're seeking a detail-oriented and organized individual to support our Regulatory Affairs and Quality Assurance (RAQA) team. We are looking for an intern who can begin in May/Jun 2025, and can commit for at least 4 months. **Key Responsibilities** - Maintain and update regulatory documentation and...

  • Director of Regulatory Affairs and Quality

    4 weeks ago

    Singapore Barrington James Full time

    Director of Regulatory Affairs and QualityDirector of Regulatory Affairs and QualityDirect message the job poster from Barrington JamesHead of Regulatory Affairs & Quality, Asia.I am engaged by a global medical devices company to appoint a Head of Regulatory Affairs and Quality for Asia.This senior leadership position will guide regulatory direction and...

  • Regulatory Affairs and Quality Assurance Manager

    3 days ago

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

    Job TitleWe are seeking a professional to oversee regulatory affairs, pharmacovigilance, and quality management control.About the RoleThe ideal candidate will have experience in managing client relationships, developing regulatory strategies, and ensuring compliance with local regulations.ResponsibilitiesDevelop and maintain client relationships and explore...

  • Senior Regulatory Affairs

    1 day ago

    Singapore River Integrity Partners Pte. Ltd. Full time $96,000 - $180,000 per year

    Senior Regulatory Affairs & Quality Assurance Executive with Global Medical Device MNCOpportunity to work on local and regional submissionsPartnering with a leading Medical Device player in its field, our client is seeking a Senior Regulatory Affairs & Quality Assurance Executive (Regional). Reporting to the RA Director, we are looking for someone with good...

  • Quality Assurance and Regulatory Affairs Associate

    5 days ago

    Singapore PRECIX PRIVATE LIMITED Full time

    **What You Do?** Quality Assurance - Overall Maintenance of ISO 13485 Quality Management System, including Change Controls to ensure suitability for departments, and creation of new Quality Procedures as required - Ensure all departments carry out due processes and documentation required to ensure all quality in all areas related to the medical device, such...

  • Surveillance Regulatory Affairs Officer

    6 days ago

    Singapore Marina Bay Sands Full time

    Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HEREBe part of our diverse and...

  • Surveillance Regulatory Affairs Officer

    3 days ago

    Singapore Marina Bay Sands Full time

    Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HERE!Be part of our diverse...