Regulatory Affairs & Quality Assurance Compliance Specialist
WGT EHR PTE. LTD.
Salary: Basic $4,500 - $6,500Allowances & Bonus: Transport $350 | AWS | Variable BonusWorking Hours: 5 Days | 8.30am-5.30pm or 9.00am-6.00pmLocation: Central - Bukit MerahCompany: MNC | Medical Device & Equipment ManufacturerBenefits: Strong benefits & career progression
Key Responsibilities
Quality Assurance & Compliance (Integrated Management Systems)
Regulatory Affairs
Environment, Health & Safety (EHS)
Requirements
Please include the following information in your resume.
By submitting any application or resume to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.
We regret only short-listed candidates will be notified.
EA License: 18C9251 WGT Group
Registration No: R22107492
Key Responsibilities
Quality Assurance & Compliance (Integrated Management Systems)
- Manage and maintain Integrated Management Systems (QMS, EMS, OHSMS).
- Lead ISO certifications and surveillance audits (ISO 9001, 14001, 45001, 13485, GDPMDS).
- Plan and conduct internal audits, compliance training, and awareness programmes.
- Drive CAPA, non-conformance management, risk assessments, and root cause analysis.
- Ensure SOPs, work instructions, and controlled documents meet regulatory requirements.
- Maintain audit-ready documentation and records for inspections and certifications.
- Monitor changes to ISO standards and regulatory requirements and implement updates.
Regulatory Affairs
- Manage regulatory submissions for Singapore, Vietnam, and Thailand markets.
- Liaise with regulatory authorities and track submission timelines.
- Maintain accurate, complete, and up-to-date regulatory documentation.
- Provide regulatory guidance to internal stakeholders on product and market matters.
Environment, Health & Safety (EHS)
- Support EHS programmes, risk assessments, and hazard mitigation initiatives.
- Conduct safety training and promote continuous improvement in EHS practices.
- Assist in incident investigations and corrective action implementation.
Requirements
- Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or related discipline.
- Minimum 5 years' experience in Quality Assurance and/or Regulatory Affairs within medical device, pharmaceutical, or healthcare industries.
- Strong knowledge of ISO standards, GDPMDS, and ASEAN regulatory requirements.
- Experience handling ASEAN regulatory submissions preferred.
- Strong documentation, audit, and stakeholder management skills.
- Good communication, organizational, and multitasking abilities.
- Certification in Regulatory Affairs or Quality Assurance is an advantage.
Please include the following information in your resume.
- Current & Expected Salary
- Reason(s) for leaving
- Notice Period / Availability to commence work
By submitting any application or resume to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.
We regret only short-listed candidates will be notified.
EA License: 18C9251 WGT Group
Registration No: R22107492
JOB SUMMARY
Regulatory Affairs & Quality Assurance Compliance Specialist
WGT EHR PTE. LTD.
Singapore
20 days ago
N/A
Full-time
Regulatory Affairs & Quality Assurance Compliance Specialist