Regulatory Affairs/Quality Assurance APAC

Greiner Bio-One APAC; Singapore; Sur place; SGD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory affairs

Quality assurance

Medical devices

Documentation

Stakeholder management

English proficiency

Formation

Bachelor's Degree in Life Sciences

Description du poste

Your challenge

We are looking for a Regulatory Affairs / Quality Assurance professional to join Greiner Bio-One Singapore and support regulatory and quality activities across the Asia-Pacific (APAC) region. In this regional role, you will work closely with local subsidiaries, distributors, and global Regulatory Affairs and Quality Management teams to support regulatory compliance, product registrations and quality-related activities across APAC markets. You will serve as an important link between regional markets and Greiner Bio-One's global functions, helping to ensure that products are compliant with applicable regulatory requirements and maintained to the company's quality standards.

Core Responsibilities

• Manage the application, renewal and maintenance of GBO-APAC local countries’ product registration and licenses; coordinate and work closely with GBO-APAC market authorized holders and GBO headquarters
• Regularly coordinate and liaise with internal stakeholders, GBO-APAC business partners, and local authorities/regulators
• Act as the Medical Devices Regulatory and Compliance Subject Matter Expert in APAC; be aware of and monitor global and local regulations and standards changes and provide advice on local and regional requirements
• Maintain regulatory documentation and ensure the registration database is updated
• Support and assist internal/external audits; participate in regulatory inspections by the external authorities/regulators
• Support, assist and provide advice of product design changes and control processes
• Support, process and manage product incidence reports, post-market
• Ensures complaints are processed and documented according to regulatory requirements
• Ensures complaints are investigated in due time and work cross-functionally with HQ on prioritization
• Assist in implementing and maintaining the local QMS, training system and related procedures.
• Support and coordinate monitoring and review of issues, customer dissatisfaction, and complaints received for APAC

Your Profile

• Bachelor’s Degree in Life Sciences, Pharmacy, Pharmaceutical Sciences, Biomedical Engineering, or a related scientific discipline.
• Minimum 3-5 years of experience in medical device or IVD product registration is preferred.
• Familiarity with national health authority registration frameworks across APAC (e.g., HSA in Singapore, TGA in Australia, NMPA in China, PMDA in Japan, TFDA Taiwan, ASEAN Medical Device Regulatory Framework).
• Familiarity with the MDSAP Audit programme.
• Strong analytical, organisational and documentation skills with excellent attention to detail.
• Good communication and stakeholder management skills, with the ability to work effectively across different cultures and countries.
• Ability to manage multiple projects and regulatory timelines independently.
• Proficiency in English; additional Asian languages would be an advantage.

Company Overview

Greiner Bio-One Singapore Pte. Ltd. is part of Greiner Bio-One, a globally active medical technology company for the in-vitro diagnostics, biotechnology, diagnostic and pharmaceutical industries. The broad portfolio is sold in more than 100 countries worldwide. By using state-of-the-art technologies, Greiner Bio-One creates the basis for top performance in pre-analytics, diagnostics, basic research and pharmaceutical drug discovery. The company operates in the market via the two business units Preanalytics and BioScience and has more than 2300 employees and 28 subsidiaries. Established in Singapore in 2022, Greiner Bio-One Singapore serves as a regional hub supporting market development and customers across the Asia and Pacific regions. Greiner Bio-One Singapore is located at 112 Robinson Road, Singapore, and works closely with colleagues, customers, distributors and regional stakeholders across the APAC market.

Why join Greiner Bio-One Singapore?

You will have the opportunity to work in a regional APAC role within a global medical technology organisation, collaborating with colleagues across different markets and functions. The position provides exposure to regulatory and quality requirements across Asia-Pacific while contributing to products and solutions that support healthcare professionals, laboratories and patient safety.

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.