IVDR Assessors / Auditors

Local Unit & Position Description: As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors throughout Europe. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 746/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Key Accountabilities:

• 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 relationships.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager.
• If required, undertake reviews of packs and make certification decisions 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.

Position Qualifications: 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
• Medicine, Veterinary Medicine
• Biomedical science
  • e.g. haematology, virology, molecular diagnostics
• Nursing
• Pharmacy, Pharmacology, Toxicology

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 / Assess, and/or experience as an assessor in a notified body (five full technical documentation assessments).
As part of this work experience, risk management experience should be covered:

• Practical experience in conducting or assessing performance evaluation data (including clinical performance data) with in-vitro diagnostic medical devices in one or more of the following areas virology, immunology, Mycology, oncology and infectious disease. knowledge regarding histocompatibility and immunogenetics, Tissue typing assays (Flow Cytometry), genetic testing and biochemistry assays.

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.
To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:

• Work in medical devices industry or closely related industries in a research and development, manufacturing, quality management or regulatory affairs capacity;
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, performance evaluations, experimental and/or clinical research, including notified bodies;
• Work in the application of device technology and its use in health care services and with patients;
• Testing devices for compliance in accordance to the relevant national or international standards;
• Conducting performance testing, evaluation studies or clinical trials of devices.

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.

Company & Business Area Description: DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.
We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.
Equal Opportunity Statement: 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!