Head of IVDR – Medical Europe

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About SCPA
We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

About the role

As part of our continued growth, we are looking to recruit a technical, and experienced, Manager for the new established In-Vitro Diagnostic team.

Reporting to the Area Manager Medical Europe, as the Head of IVDR Medical Europe you will be responsible for the development of the business, implementation of the business strategy, as well as recruitment, development and support of additional resources within this area. The role is also expected to support the sales organisation with the development of the certification proposals and interact with customers as required.

The Medical Devices area is an important part of DNV’s strategy moving forward - the Head of IVDR Medical Europe will play a critical part in the continued rapid growth of the DNV’s medical devices services, being a champion for quality with a responsibility for designing, developing, maintaining, and implementing the Medical Devices governance framework within the Region Europe.

We seek a strategic, commercially minded, leader, a self-driven and confident individual who excels in an international, dynamic, and agile environment and possesses strong social and communication skills to build trust at all levels. This is an exciting opportunity for a forward-thinking Technical Manager who is passionate about upholding standards to the highest level. You will have the opportunity to work alongside a global team of experts and be an influential figure in DNV’s continued success.

The Head of IVDR Medical Europe shall actively promote, support and strive to meet DNV’s Purpose, Vision and Values, and shall sustain a culture of cooperation across the Supply Chain & Product Assurance and wider DNV business. The Head of IVDR Medical Europe shall, at all times, have DNV’s best interest in focus – and lead and facilitate necessary initiatives to ensure DNV complies with all regulatory and accreditation requirements relevant for medical devices services and meet expectations on knowledge and competence from authorities, market units, customers and other partners.

The role is full-time and can be based anywhere in Europe.

Since this team is currently being implemented, the role is divided into both being a manager as well as either an IVDR assessor or auditor:

Key Accountabilities: Manager

• Be responsible for implementation of IVDR and ensure compliance with applicable regulatory requirements and standards.
• Work closely with the Head of Technical, Quality & Governance, Head of Business Development and Head of Planning, as well as other key internal stakeholders to enhance the operational cooperation and interaction within the medical services delivery and promote best practice sharing. Ensure to provide or address technical support when needed to the same functions.
• 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.
• Manage individual performance of all direct reports and extended team.

Key Accountabilities: Assessor

• Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
• Complete specific 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 decisions within target timescales and in line with DNV policies and accreditation/approval requirements.

Key Accountabilities: Auditor

• 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.

What we offer

Our working culture is based on respect for one another and the appreciation of work-life balance.

• A competitive salary and benefits package
• A stimulating and diverse work environment with opportunities for professional growth and development – learn from highly skilled colleagues and customers
• A supportive and friendly team of experts and innovators
• Social benefits as per DNV location (local conditions apply)

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.

Position Qualifications: Manager

• Excellent knowledge and understanding of the Medical Device industry, preferably with experience covering both Notified Body’s and Industry / Manufacturing / Pharmaceutical companies.
• Ability to represent the company by participating in internal audits with accreditation bodies.
• Ability to use analytical data in order to monitor and drive performance excellence.
• Excellent communication and presentation skills; ability to interpret and present highly complex and strategically significant information.
• Bachelor’s degree is required, Master’s degree or higher is a plus.
• Excellent written and verbal English communication skills.
• Ability and willingness to travel when required.
• Solution oriented mind-set combined with a pragmatic approach.
• Takes keen interest in driving change wherever required.
• Excellent communication and interpersonal skills.
• Strong software skills (Excel and PowerPoint).
• Optimism, creativity and passion to make a difference in the market.

Position Qualifications: Assessor/Auditor

• Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.
  In-Vitro Diagnostic devices:
  • Biology or Microbiology
  • Chemistry or Biochemistry
  • Human Physiology
  • Medical Technology or Biotechnology
  • Medicine, Veterinary Medicine
  • Biomedical science - e.g. haematology, virology, molecular diagnostics
  • Nursing
  • Pharmacy, Pharmacology, Toxicology
  • Physiology
• In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically:
  • Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices.
  • Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology.
• A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.

In addition to the above, knowledge of the following would be preferred:

• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques;
• Work experience in positions with significant QA Regulatory or management systems responsibility;
• Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices;
• Experience with Risk Management EN ISO 14971;
• Medical device experience from auditing/work;
• Experience auditing against recognized standards;
• Experience of working under own initiative and in planning and prioritizing workloads;
• Should have a flair for technical writing, essential for exhaustive report writing.

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