Regulatory & Quality Assurance Leader (ISO/GDPMDS)

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

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.