The life sciences regulatory landscape has changed significantly since the start of 2020. New regulations, designed to encourage the rapid (safe) development of vaccines, tests and treatments for COVID-19, have been introduced. But the impact of these changes will reach beyond the drug development pipeline. Our recruitment experts explain what these changes mean for life sciences businesses, and how they could affect recruitment over the coming years.
Some of the most impactful regulations that have come into play are the EU’s new Medical Device Regulations (MDR) and the impending ‘Regulation on in vitro diagnostic medical devices’.
The new regulations aim to ensure safety standards are maintained at the highest level, with an increased focus on clinical evidence, risk management and quality assurance. But they also mean that all existing medical devices need to be recertified - with additional evidence required to support those aims.
A survey by MedTech Europe suggests that more than 20% of in vitro diagnostic (IVD) tests will be discontinued rather than submitted for recertification. There will be a 10-fold increase in the number of devices that need a Notified Body certificate, and more than half of organizations that took the survey do not have an existing agreement with a Notified Body.
Combined, these factors mean that the medical device industry is currently enduring a labor-intensive period of regulatory work, but with limited access to the professionals required to do that work.
New regulatory professionals
Unsurprisingly, this is a key area affected by the current life sciences talent shortage. That means you can expect serious competition to find and secure the right regulatory affairs (RA) candidates. So how can you ensure that your company has the people it needs when it needs them? Our talent experts share their top tips:
Consider outsourcing non-managerial roles. Long lead times and high demand mean that hiring new employees is not always the most efficient choice. It might be worth spending a little extra to secure a short-term resource who can hit the ground running.
Search outside of your usual Life Sciences network. You can find skilled professionals with the ability to understand life sciences regulations in other fields, such as quality assurance/control, R&D and engineering.
Consider in-house candidates, particularly those who have shown good detail orientation, prioritization skills and have worked on reports, dossiers and submissions. Remember, you can train management skills and offer coaching and mentorship to nurture promising employees, so don’t be afraid to help them make that leap.
And of course, there are professional conferences and bodies such as the international Regulatory Affairs Professional Society (RAPS) that can provide networking opportunities to help you find that RA talent you need.
For senior roles in particular, consider partnering with recruitment experts such as Kelly Life Sciences. Specialist life sciences recruiters have a fantastic connection with all kinds of organizations and professionals within the industry. This includes being involved with professional associations and university alumni networks, as well as partnering and sponsoring events. Engaging in partnership with teams like Kelly can expand your network within a matter of days and help you find not just a person for the job, but the best person.