Regulatory Affairs & Quality Assurance Compliance Specialist

WGT EHR Pte. Ltd.; Singapore; On-site; SGD 4,000 - 7,000; Full time

Job summary

A leading medical device manufacturer in Singapore is seeking a Regulatory Affairs & Quality Assurance Compliance Specialist to manage Integrated Management Systems and lead ISO certifications. This role requires a Bachelor's Degree in a relevant field and a minimum of 5 years' experience in Quality Assurance within the medical device industry. Strong knowledge of ISO standards and ASEAN regulatory requirements is essential. The position offers a competitive salary range and strong career progression opportunities.

Benefits

Strong benefits

Career progression

Qualifications

• Min 5 years’ experience in Quality Assurance and/or Regulatory Affairs within medical device, pharmaceutical, or healthcare industries.
• Experience handling ASEAN regulatory submissions preferred.
• Certification in Regulatory Affairs or Quality Assurance is an advantage.

Responsibilities

• Manage and maintain Integrated Management Systems (QMS, EMS, OHSMS).
• Lead ISO certifications and surveillance audits (ISO 9001, 14001, 45001, 13485, GDPMDS).
• Manage regulatory submissions for Singapore, Vietnam, and Thailand markets.

Skills

ISO standards knowledge

Strong documentation skills

Audit management

Stakeholder management

Education

Bachelor’s Degree in Life Sciences, Pharmacy, Chemistry, or related discipline

Job description

Regulatory Affairs & Quality Assurance Compliance Specialist

Salary: Basic $4,500 – $6,500
Allowances & Bonus: Transport $350 | AWS | Min 1.5 mths Variable Bonus
Working Hours: 5 Days | 8.30am–5.30pm or 9.00am–6.00pm
Location: Central – Bukit Merah
Company: MNC | Medical Device & Equipment Manufacturer
Benefits: Strong benefits & career progression

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.
• Min 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.
• 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