IVDR
The European IVDR regulation was announced back in 2017, and it arrived with a five-year period of transition. The rule is in place to ensure that medical device manufacturers continue making the safest and most effective products possible. While the rule is designed to improve the quality and safety of products everywhere, the legislation poses an entirely new set of challenges in the life sciences space.
One of these challenges is the lack of communication between regulatory authorities and device manufacturers, resulting in increased lead times, greater production costs and a labyrinthian passage to market. Greater communication efforts between organisations (on an international scale) will likely improve the implementation of the IVDR rule, and in order to reach this point, companies will need to hire the right people.
IVDR regulations can be difficult to navigate and understand at the best of times, but when you haven’t got the right regulatory function supporting you, the task quickly becomes damaging for your brand and your processes. The EU IVDR regulations will need to be observed by professionals with experience in managing projects governed by this rule.
These professionals can be hard to find if you don’t know what kind of skillsets you should be looking out for. This is where the team at BioTalent come in. We can match you with the perfect candidate to fill a gap in your IVDR regulatory function, enabling your medical devices to reach the market in time and within budget, all while keeping in line with the compliancy laws.
Failure to comply can result in disaster, not only for your company, but for the public that rely on medical devices to fulfil their needs. Fear not, however, as the IVDR transitional period has been extended until May of 2027, allowing you to build and develop a sturdy compliance function in the meantime. We have access to an expansive global talent network, enabling us to cherry pick the perfect candidate for your specific needs as a business.
Our specialist consultants have a deep knowledge of regulation, and have a wealth of experience in hiring in this area for companies all over the world. We know that plenty of CVs look good on paper, but when the time comes to do the job, it can be hard to know who’s going to make the grade. We get to know all of candidates’ strengths and weaknesses, and we devise hiring solutions led by a DEIB-focussed philosophy, enabling us to reach out to a much larger talent pool and select individuals who have the skills and the mindset to truly belong with your organisation.
The implementation of the IVDR regulations is likely going to represent a difficult time for countless businesses operating within the life sciences, so it’s important that you build a team that can give you a competitive edge. Whether that’s a single hiring or an entire department’s worth of regulatory affairs jobs, we can map out the best way to help you thrive, and deliver on our word, enabling you to benefit from a right-first-time approach to hiring for a sustainable future in the life sciences.