Medtech Recruitment: MDR and IVDR Expertise

The Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) have changed what it takes to bring a product to market in Europe. Requirements for clinical evidence, quality systems and post-market surveillance are stricter, and many products have to be certified again. For medtech companies this has created a great need for specialist expertise – and fierce competition for the same candidates.

Here we look at which roles are most in demand, which deadlines affect the market, and how to recruit well.

The deadlines driving demand

The transition periods have been extended several times, but they are coming to an end:

MDR: Where the conditions are met, legacy devices can still be placed on the market until 31 December 2027 for class III and most implantable class IIb devices, and until 31 December 2028 for other classes that require a notified body.
IVDR: The transition periods run until 31 December 2027 for class D, 31 December 2028 for class C and 31 December 2029 for class B and sterile class A devices, also subject to conditions.

When manufacturers across Europe work towards the same deadlines, demand for people who have done the job before increases. It pays to recruit well before the documentation is due.

The roles in highest demand

Regulatory Affairs specialists with experience of technical documentation, classification and notified body dialogue. See also our article on Regulatory Affairs recruitment.
QA and quality systems with experience of ISO 13485, internal audits, supplier management and CAPA.
Clinical evaluation and performance evaluation – under the MDR this means clinical evaluation, under the IVDR scientific validity, analytical and clinical performance.
Post-market surveillance (PMS) and vigilance, including trend analysis and incident reporting.
Software as a medical device, with expertise in software lifecycle processes, cybersecurity and risk management.
Design and verification engineers, risk management under ISO 14971 and usability.

PRRC – a role many forget

Both the MDR and IVDR require manufacturers to have at least one person responsible for regulatory compliance, often called the PRRC. The person must have documented expertise through education and experience in regulatory affairs or quality management for medical devices.

Micro and small enterprises do not need to employ the PRRC within their own organisation, but must have permanent and continuous access to such a person. For growing companies, it is still often a good idea to build the expertise in-house over time.

Candidates from pharma, engineering or medtech?

Because the candidate market is small, it is tempting to recruit from adjacent fields. This can work well, but be aware of what transfers:

From pharma: Strong regulatory and quality understanding, but the regulations and documentation for medical devices are different. Expect a learning curve.
From engineering: Good understanding of design, testing and risk management, but often less experience with regulatory documentation.
From other medtech companies: The fastest to get up to speed, but also the most sought-after – and often the hardest to move.

A good solution can be to combine one experienced key person with candidates who have a strong technical background and learn the regulations along the way.

Start-up or established manufacturer?

A start-up often needs one or two people who can build the quality system and regulatory strategy from scratch. An established manufacturer more often needs specialists who can take responsibility for a product portfolio or part of the quality system. The profiles differ, and this should be reflected in the job specification.

Tips for the recruitment process

Test understanding concretely. Ask the candidate to classify a product, or explain how they would structure the technical documentation.
Ask about notified bodies. How has the candidate handled questions or nonconformities from an audit?
Clarify regulation and markets. Do you need EU expertise only, or also FDA and other markets?
Move quickly. Good medtech candidates receive many approaches.

How Oslo Life Sciences can help

Oslo Life Sciences recruits for medtech, medical devices and diagnostics – from MDR/IVDR specialists and Quality Engineers to design, process and R&D engineers, verification and leadership. We know the difference between the requirements of the MDR and IVDR, and assess candidates' experience against what you actually need to deliver. We search in Norway, the Nordics and the DACH region, home to many of Europe's medtech communities.

Working with diagnostics and laboratories? Read about recruitment in pathology, diagnostics and laboratory.

Frequently asked questions

What is the difference between the MDR and IVDR?

The MDR (Regulation (EU) 2017/745) covers medical devices in general. The IVDR (Regulation (EU) 2017/746) covers in vitro diagnostic devices, such as tests and reagents used to analyse samples from the human body.

What do the transition periods mean for recruitment?

That many manufacturers need the same expertise at the same time. The closer the deadlines, the fiercer the competition for experienced candidates.

Can the PRRC role be outsourced?

Micro and small enterprises may have permanent and continuous access to a PRRC without employing the person. Larger manufacturers must have the person within their own organisation.

Does a medtech engineer need regulatory experience?

Not always, but an understanding of risk management, verification and documentation is a great advantage. Clarify in the job specification what is a must-have and what can be learned.