ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung

About the Position

ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung

Join DNV as an ISO13485 & MDR Auditor/Assessor in Taipei or Kaohsiung, Taiwan, ensuring compliance with international standards in medical device regulation.

Responsibilities

• Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards, and other applicable regulatory requirements following DNV’s accredited certification program and procedure.
• Ensure independent and ethical auditing activities, upholding DNV’s values of integrity and impartiality.
• Contribute to continuous improvement efforts by identifying and driving enhancements in audit processes, information management, and service delivery across teams.
• Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned.
• Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities.
• Perform additional duties as assigned by the line manager to support team and business objectives.

Requirements

• Relevant Bachelor or higher degree related to medical science and medical device area. Core disciplines: biology or microbiology; biomechanical engineering; chemistry or biochemistry, medicine and clinic practice; computer and software technology; electrical, electronic, mechanical, or bioengineering.
• Minimum 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments. Prefer product group: MDN1206 non-active ophthalmologic device, MDN1201 non-active device for anesthesia, emergency and intensive care, MDN1202 non-active device for administration, channeling, and removal of substances, including dialysis.
• High customer focus and service orientation.
• Strong communication and interpersonal skills.
• Proven ability to work collaboratively in teams and across functions.
• Self-motivated with strong commitment to continuous learning and development.
• Fluency in both written and spoken English is required.

We Offer

• Flexible work arrangements for better work-life balance.
• Generous Paid Leaves (Annual Paid Leave, Sick Leave).
• Medical benefits (Standard medical check-up).
• Pension and Insurance Policies.
• Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme).
• Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Professional Membership Fees).

Benefits may vary based on position, tenure/contract/grade level.

About the Company

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

Diversity, Equity, and Inclusion

At DNV, our commitment to Diversity, Equity, and Inclusion is not only an ethical choice, but also a business decision. Diversity, fairness, and a sense of belonging are a source of strength for our people, our business, and our customers, and help us to deliver on our purpose, vision, and values.

Working Here

Since 1864 we’ve been dedicated to safeguarding life, property, and the environment. Today we remain at the forefront of new technologies and techniques to help our customers transform for a more sustainable future.

At DNV you can expect to deliver career and industry-defining work. You’ll be given the time to build your network, the resources to support your development, and the freedom to satisfy your curiosity and desire to learn.

Application Process

You can apply directly through our careers page by submitting your CV and any other documents we require (i.e., university diplomas/transcripts; visas; previous employment reference letters*). Make sure your application is fully completed, and you tailor it to the specific job listing.

FAQs

How can I find job openings that fit my skills and interests?

Explore our official job search page where you can use filters such as job type, location, and department to find roles that best match your qualifications and career aspirations.

What’s your application process like?

You can apply directly through our careers page by submitting your CV and any other documents we require (i.e., university diplomas/transcripts; visas; previous employment reference letters*). Make sure your application is fully completed, and you tailor it to the specific job listing.

Is your recruitment process designed to be inclusive and accessible?

Yes, it is. We're an equal opportunities employer and welcome applications from all candidates. We’re happy to support your need for any adjustments during the application and hiring process. Share the details of what you need within your application.

What types of interviews might I undergo?

Depending on your role, our interview process may include initial phone screenings, video conferences, and in-person interviews, focusing on both your technical abilities and our shared values. You can ask your recruiter specifically about the interview process for your role.

How long does the hiring process typically take from application to decision?

The timeline can vary but we make every effort to reply to each candidate as soon as possible and keep everyone up-to-date with where they are in the recruitment process.

How do I know if a recruitment contact is legitimately from your company?

Official communication will come from our verified company email addresses. Carefully check any suspicious looking emails and if you have any doubts, don’t engage.

Are there any fees involved in your recruitment process?

No, we do not charge any fees at any stage of our recruitment process. All applications and interviews are free of charge, we will never ask you to pay any fees or make any payments – please be wary of any requests for payment as these are likely scams.

What should I do if I suspect a job scam?

If you encounter suspicious job postings or recruitment practices, do not provide personal information and contact your recruiter as soon as possible. We take these matters seriously. We will never ask you to pay any fees or make any payments part of our recruitment process.

Does DNV complete background checks?

Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.

Please ask your recruiter for further details.

Join Our Talent Community

Can't find the right fit?

Be the first one to learn about new job opportunities that might be a perfect fit for you.

Disclaimer

Please beware of recruitment scams that pretend to be from DNV or its employees. We will never ask you to pay any fees or make any payments as part of our recruitment process.