Technical Manager - IVDR

Job Summary:

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.

 Key Responsibilities:

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,

Business Development

• Drive and implement the sales and business development initiatives to promote Medical certification services,
• Interface with customers and follow up on leads and sales conversions
• Addressing technical queries with customers
• Preparation of effort estimations and commercial proposals
• Lead generations through public webinars/workshops, representation on relevant forums

Customer Relationship Management

• Building trusted relationships with customers and internal stakeholders
• Communication with customers on the execution status of the certification activities.

• Flexible work arrangements for better work-life balance
• Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave)
• Medical benefits ( Insurance and Annual Health Check-up)
• Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance)
• Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
• Additional Benefits (Long Service Awards, Mobile Phone Reimbursement)
• Company bonus/Profit share.

*Benefits may vary based on position, tenure/contract/grade level*
 

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.

Education:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Medical Technology, or a related field.

Experience:

• At least 10+ years of experience in regulatory affairs, technical documentation, or quality management in the medical device or in vitro diagnostics industry.
• At least 4 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/ invitro devices.
• Experience working with Notified Bodies and regulatory authorities.
• Exceptional problem-solving and analytical skills.
• Excellent organizational and time management abilities
• Strong communication and project management skills, with the ability to work collaboratively in cross-functional teams.
• Experience in auditing for IVDR compliance.
• Relevant exposure to commercial activities/business model.