IVDR Technical Manager

We are seeking an experienced and highly motivated IVDR Technical Manager to join our team. In this role you willlead and facilitate necessary initiatives in order to ensure DNV complies with all regulatory and accreditation requirements relevant for invitro 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 Youll Do:

Competence Management

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

Crossteam 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 crossfunctional 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 onboarding program for new staff that is varied engaging and ensures they are set up for success

Generous Paid Time Off (Vacation Company Holidays Parental Leave Sick and Disability).

• Multiple Medical Dental and Vision Benefit Plans to choose from.
• Spending Accounts FSA Dependent Care Commuter Benefits CompanySeeded HSA.
• 401(K) with company match.
• Company provided life insurance shortterm and longterm disability benefits.
• Education reimbursement program.
• EmployerPaid therapistled virtual care services through Talkspace.
• Flexible work schedule with hybrid/remote opportunities.

**Benefits may vary based on position tenure location and employee election

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 (). Information received relating to accommodations will be addressed confidentially.

What Is Required:

Education:

• Bachelors or Masters degree in Life Sciences Engineering Medical Technology or a related field.

Experience:

• At least 5 years of experience in regulatory affairs technical documentation or quality management in the medical device or in vitro diagnostics industry.
• At least 2 years of direct experience with IVDR or its predecessor IVDD (In Vitro Diagnostic Directive).
• Experience in preparing and submitting technical files design dossiers and risk management documentation for IVD products.

Skills & Competencies:

• Strong understanding of the IVDR and EU regulatory requirements for IVD products.
• Excellent knowledge of technical documentation practices including risk assessments clinical evaluations and performance studies.
• Knowledge of ISO 13485 and other relevant standards for medical devices.
• Experience working with Notified Bodies and regulatory authorities.
• Exceptional problemsolving and analytical skills.
• Excellent organizational and time management abilities
• Strong communication and project management skills with the ability to work collaboratively in crossfunctional teams.
• Experience in auditing for IVDR compliance.
• We conduct a preemployment background check and drug screen.

*Immigrationrelated employment benefits for example visa sponsorship are not available for this position*