IVDR Lead Auditor

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.

Responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

• Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits.
• Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Complete all chargeable work within the required time frames 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.
• If required, 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, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

• Flexible work schedule with hybrid working opportunities for better work-life balance
• Generous paid leaves (annual paid leave, special paid leave)
• Pension and Insurance policies (corporate life insurance, local group insurance, travel insurance, retirement pension)
• Additional benefits (meal allowance, transportation allowance, holiday bonus, tuition assistance for children, annual medical check-up, long service awards)
• Competitive salary along with profit share

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.

• Auditors shall have a technical college degree in a relevant product or medical area, as described below.
  In-Vitro Diagnostic devices:
  • Biology or Microbiology
  • Chemistry or Biochemistry
  • Human Physiology
  • Medical Technology or Biotechnology
  • Medicine, Veterinary Medicine
  • Biomedical science - e.g. haematology, virology, molecular diagnostics
  • Nursing
  • Pharmacy, Pharmacology, Toxicology
  • Physiology
• In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) 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.
  
  Specifically:
  • 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.

• An 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;
• Medical device experience from auditing/work;
• Experience auditing against recognized standards;
• Experience of working under own initiative and in planning and prioritizing workloads;
• Should have a flair for technical writing, essential for exhaustive report writing.

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.