Medical Device ISO 13485 Auditor / Assessor (Homebased)

Role overview

BSI is looking for a Medical Device Assessor based in Singapore to work from home while travelling as needed. In this position, you will support medical device manufacturers across the APAC region by evaluating their ISO 13485 quality management systems. The goal is to help these organizations improve performance, maintain patient safety, and meet applicable regulatory requirements.

What you will do

During your first six months, you will receive structured training in ISO 13485 Lead Auditor practices, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation). At first, you will shadow audit activities and later progress to carrying out audits independently both onsite at manufacturer locations across APAC and remotely from your home office.

Once fully trained, your regular work will include conducting audits in person or remotely, preparing reports, coordinating with the planning team to keep the audit calendar on track, and continuing your development in MDR. You will also represent and support the ISO 13485 APAC Delivery Team.

What BSI is looking for

Applicants should have an academic background in electrical engineering, computing/IT, or physics, along with a degree in a medical-device-related discipline such as chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology, or a comparable field. You must have at least 4 years of direct responsibility for the design, testing, or manufacturing of medical devices.

Experience in active medical device R&D is mandatory, and software experience is preferred. You should also have a minimum of 2 years of experience in an environment where a Quality Management System was in place. Strong exposure to active medical devices, electrically powered products, and software lifecycle processes for medical, health, or other safety-critical software is required, together with relevant regulatory and standards knowledge.

Fluency in both spoken and written English is essential. The role also requires resilience and a willingness to travel frequently across APAC to complete audit assignments. Candidates must hold a Singapore Employment Pass or be a Singapore citizen. BSI is also open to applications from candidates based in Malaysia who are interested in this opportunity.

About BSI

BSI is a business improvement and standards organization with a long history of helping people, organizations, and society progress. The company works with more than 77,500 clients across 195 countries and has a global network of over 15,000 experts, as well as industry, consumer, organizational, and government stakeholders.

Through its work across sectors including automotive, aerospace, built environment, food and retail, and healthcare, BSI helps clients achieve their goals and address major challenges such as climate change and digital trust. The organization is guided by client-centricity, agility, and collaboration, and is committed to supporting a more sustainable and better society. BSI is an equal opportunity employer and values a diverse and inclusive workplace.

Additional information

This role is homebased in Singapore and involves regular travel across the APAC region. The employer has stated that local hire is required, with Singapore EP or Singapore citizenship needed. Candidates from Malaysia are also encouraged to apply if they are interested in the role.