APAC Regulatory & Quality Lead (Medical Devices)

Greiner Bio-One APAC; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Greiner Bio-One APAC seeks a Regulatory Affairs / Quality Assurance professional to support regulatory compliance, product registrations and quality activities across the APAC region. You will collaborate with local subsidiaries, distributors and global teams to ensure products meet regulatory requirements and quality standards.

In this regional role, you will be the link between APAC markets and Greiner Bio-One’s global functions, guiding regulatory strategies and maintaining robust quality

Qualifications

• Bachelor’s degree in Life Sciences or related field is required.
• 3–5 years of experience in medical device or IVD product registration preferred.
• Familiarity with APAC regulatory frameworks (HSA, TGA, NMPA, PMDA, TFDA, ASEAN MDR) is expected.
• Familiarity with MDSAP audit programme is a plus.
• Strong analytical, organizational and documentation skills with attention to detail.
• Excellent communication and stakeholder management across cultures.

Responsibilities

• Manage local country product registration, renewals and licenses for APAC; coordinate with market holders and HQ.
• Coordinate with internal stakeholders, partners and regulators.
• Act as Regulatory and Compliance SME for APAC; monitor regulatory changes and advise on regional needs.
• Maintain regulatory documentation and the registration database.
• Support internal/external audits and regulatory inspections.

Skills

Regulatory affairs

Quality assurance

Medical devices

Documentation

Stakeholder management

English proficiency

Education

Bachelor's Degree in Life Sciences

Job description

Greiner Bio-One APAC seeks a Regulatory Affairs / Quality Assurance professional to support regulatory compliance, product registrations and quality activities across the APAC region. You will collaborate with local subsidiaries, distributors and global teams to ensure products meet regulatory requirements and quality standards.

In this regional role, you will be the link between APAC markets and Greiner Bio-One’s global functions, guiding regulatory strategies and maintaining robust quality