IVDR Experienced Assessor

2 weeks ago

Houston, TX, United States DNV GL Full time

We are seeking an experienced and highly motivated IVDR Assesor 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.

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.

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