IVDR Experienced Assessor

We are seeking an experienced and highly motivated IVDR Assesor to join our this role you willlead 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.

What Youll Do:

• Responsible to carry out audits of the manufacturers 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.

• 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 throughTalkspace
• 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 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 (). 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

*Immigration-related employment benefits for example visa sponsorship are not available for this position*