ISO13485 & MDR Auditor/Assessor – Taipei & Kaohsiung

About the role

DNV is seeking an experienced ISO13485 & MDR Auditor/Assessor to join its team in Taiwan. You will work on audits and assessments of medical device manufacturers, ensuring compliance with international standards and regulations.

Key responsibilities

• Conduct audits and assessments in accordance with ISO13485, MDSAP and MDR, following DNV’s accredited certification procedures.
• Uphold independence and ethical standards, reflecting DNV’s values of integrity and impartiality.
• Identify and drive improvements in audit processes, information management and service delivery.
• Plan and deliver client projects such as gap analyses, training workshops and other consultancy activities.
• Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant authorities.
• Perform additional duties assigned by the line manager to support team and business objectives.

Required profile

• Bachelor’s degree or higher in a medical‑science or medical‑device related discipline (e.g., biology, biomedical engineering, chemistry, medicine, computer/software technology, electrical/mechanical engineering).
• Minimum 4 years of hands‑on experience in design, manufacturing, testing or clinical use of medical devices.
• Experience with product groups such as non‑active ophthalmologic devices, anesthesia devices, intensive‑care devices, and devices for administration or dialysis.
• Strong customer focus and service orientation.
• Excellent communication skills.

Required skills

• ISO13485 auditing
• MDR (Medical Device Regulation) auditing
• MDSAP auditing
• Medical‑device regulatory compliance knowledge
• Gap analysis and audit report writing
• Training workshop delivery

What we offer

• Flexible work arrangements for better work‑life balance
• Generous paid leave (annual and sick leave)
• Medical benefits including standard health check‑ups
• Pension and insurance policies
• Training and development assistance (sponsorship, on‑the‑job training, programmes)
• Additional benefits such as long‑service awards, mobile‑phone reimbursement and professional‑membership fee coverage