IVDR Experienced Auditor
DNVWe are seeking an experienced and highly motivated IVDR Auditor to join our team. In this role, you will lead and facilitate necessary initiatives in order to ensure DNV complies with all regulatory and accreditation requirements relevant for in-vitro devices services and meet expectations on knowledge and competence from authorities, market units, customers and other partners. The ideal candidate will have a strong background in regulatory affairs, technical documentation, and quality management systems, with the ability to manage the technical aspects of IVDR compliance for a diverse portfolio of IVD products. This position can be remote from anywhere in the Continental U.S with travel to customer sites up to 75% of the time
What You'll Do:
- 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 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.
- 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.
Responsibilities
- Generous paid time off (vacation, sick days, company holidays, personal days)
- Multiple Medical and Dental benefit plans to choose from, Vision benefits
- Spending accounts – FSA, Dependent Care, Commuter Benefits, company-seeded HSA
- Employer-paid, therapist-led, virtual care services through Talkspace
- 401(k) with company match
- Company provided life insurance, short-term, and long-term disability benefits
- Education reimbursement program
- Flexible work schedule with hybrid/remote opportunities
- Charitable Matched Giving and Volunteer Rewards through our Impact Program
- Volunteer time off (VTO) paid by the company
- Career advancement opportunities
**Benefits may vary based on position, tenure, location, and employee election
DNV is a proud equal opportunity employer committed to building an inclusive and diverse workforce. All employment is decided on the basis of qualifications, merit or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment department (hrrecruitment.northamerica@dnv.com). Information received relating to accommodations will be addressed confidentially.
For California, Washington, New York, Washington, D.C., Illinois, and Maryland: “DNV provides a reasonable range of compensation for this role. The actual compensation is influenced by a wide array of factors, including but not limited to skill set, level of experience, and specific location. For the states of California, Washington, New York, Washington, D.C., Illinois, and Maryland only, the starting pay range for this role is $95000- $175000.
Deadline to Apply: Aug. 22, 2025
Qualifications
What Is Required:
Assessors and 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. hematology, 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 or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically:
Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices.
Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology.
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.
In addition to the above, knowledge of the following would be preferred:
- 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.
- We conduct a pre-employment background check and drug screen.
*Immigration-related employment benefits, for example visa sponsorship, are not available for this position*