Job Description, Responsibilities & Requirements
About the Position
IVDR Lead Auditor
Location: Seoul, South Korea
Business: Life Sciences
Position type: Full Time
Contract type: Permanent Employee
Job ID: 6773
About Us
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.
About Life Sciences
We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers-driving sustainable results and improved ESG performance.
Responsibilities
- Plan and conduct audits against the manufacturing of medical devices in accordance with ISO 13485, IVDR 2017/746, and MDSAP standards.
- Carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors.
- Conduct surveillance audits including follow-up activities in accordance with established procedures.
- Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
- Complete projects in relation to IVDR procedures, processes, systems, and documentation as requested by the Operations Manager.
- Undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements.
- Project manage auditing teams to maximize efficiencies, enhance client satisfaction, and ensure compliance with standards.
Requirements
- A technical college degree in a relevant product or medical area such as Biology, Microbiology, Chemistry, Biochemistry, Human Physiology, Medical Technology, Biotechnology, Medicine, Veterinary Medicine, Biomedical science, Nursing, Pharmacy, Pharmacology, Toxicology, or Physiology.
- Minimum 4 years’ work experience in an In-Vitro diagnostic medical device related industry, academia, or hospital environment, with at least 2 of these years in the design, manufacturing, testing, or use of the device in which they are qualified to Audit, and/or experience as an auditor in a notified body.
- Practical experience in the quality management system and specific production process/technologies for the IVD medical devices.
- A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture, or testing.
Preferred Skills
- Excellent working knowledge of medical device management systems, standards, and medical device compliance/auditing techniques.
- Work experience in positions with significant QA Regulatory or management systems responsibility.
- Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices.
- Experience with Risk Management EN ISO 14971.
- Experience of working under own initiative and in planning and prioritizing workloads.
- Flair for technical writing, essential for exhaustive report writing.
What We Offer
- Flexible work arrangements for better work-life balance
- Generous Paid Leaves (Annual Paid Leave, Special Paid Leave)
- Pension and Insurance Policies (Corporate insurance policies, Accident insurance, Unemployment insurance, Medical insurance, National Pension, Travel insurance)
- Additional Benefits (Long Service Awards, Retirement Allowances, Housing Allowances, Festive Allowances, Transportation Allowances, Meal Allowances, Tuition Assistance for Employees Kids)
- Benefits may vary based on position, tenure/contract/grade level
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age, or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.
About the Company
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.
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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.