IVDR Technical Manager

We are seeking an experienced and highly motivated IVDR Technical Manager 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.

What You'll Do:

Competence Management

• Manage the competence process for all technical roles as per the accreditation and regulatory requirements in DNV's procedures. This includes the initial qualification as well as maintaining them.

Cross-team Collaboration

• Work closely with the sales and planning functions, as well as other key internal stakeholders to enhance the operational cooperation and interaction within the IVDR services delivery and promote best practice sharing. Ensure to provide or address technical support when needed to the same functions.
• Proactively identify and recommend process improvements.

Compliance and Regulatory Updates

• Work with cross-functional teams to ensure all stakeholders are informed of IVDR requirements and compliance statuses.
• Stay updated on changes in IVDR, EU regulatory requirements, and industry best practices.
• Provide training and support to internal teams regarding IVDR compliance and regulatory updates.

Team Development and Training

• Ensure the team have all the knowledge needed to carry out work to a high level. When and where required, identify training and development to guarantee there is a culture of continuous performance,
• Take part and be responsible for the hiring of new staff. Recognizing where the gaps are and building a team that is motivated, talented and diversified.
• Design an on-boarding program for new staff that is varied, engaging and ensures they are set up for success,