Medical device rules cause German regulatory affairs shortageBy Dominik Hilbl, Senior Consultant, i-Pharm Frankfurt
The new European medical device regulation (MDR) finally came fully into effect on 26 May 2021 and, while many companies were well prepared, it is causing challenges for a significant number of players in the German market. Germany’s medical devices industry is not dominated by big players but rather by a sizeable roster of companies of fewer than 400 employees, many family-owned, that have simply not had the opportunity to get ahead of the new rules given the turbulent times of the past 18 months.
The situation is creating an enormous boom in demand for experienced regulatory affairs managers that are capable of supporting existing teams with the final transition phase for the new rules. Experienced quality managers are also highly sought after to pass audits regarding the MDR; across the board, we find clients desperate for managers that can speak the same language as the notified bodies.
There is a real shortage of the necessary talent in the DACH region, further compounded by preparations underway for the upcoming in vitro diagnostic regulation (IVDR), which comes into force next year. Those impacted by that legislation would do well to learn the lessons of 2020, when many businesses didn’t fill the regulatory positions they should have filled to prepare for MDR, in part because of Covid-related insecurities.
Everyone is trying ramp up resources in regulatory affairs, because there are huge workloads in teams that are grappling with new regulations, new documents and new submissions. But experienced managers are almost impossible to get, not least because so many switched jobs in order to start new roles at the beginning of this year, hired by businesses getting ahead of the game.
Today, we find ourselves supporting so many clients looking for regulatory talent at a time when the experienced individuals being sought are really thin on the ground.
Today, we find ourselves supporting so many clients looking for regulatory talent at a time when the experienced individuals being sought are really thin on the ground. In Bavaria the problem is particularly acute thanks to the sheer density of mid-sized medical device companies looking to hire. I spoke to one client that had advertised at the beginning of May for a basic regulatory affairs manager position and did not receive a single appropriate response.
Are there any answers? If there is one thing that sets companies apart in this climate, it is the ability to offer flexible or home-based working options to candidates that could be tempted to move. Many of the more experienced regulatory affairs professionals have worked effectively from home full-time through the pandemic and see little need to return to the office. While most appreciate the need to make connections face-to-face upon starting a new role, by giving candidates the option to work three or more days a week remotely, clients can significantly expand the talent pool they are fishing in.
Another way to cast the net wider is through investment in the technology to translate complex technical documentation from German to English, thus opening up the possibility of hiring from beyond the DACH region. Many of the mid-market German medical device manufacturers still run all their documentation in German and are barely digitised, making them far less attractive to talented candidates from India and elsewhere.
Today’s shortage of talent has come about because so few businesses adequately prepared in advance for MDR. We’re advising those likely to impacted by IVDR next year to start planning their hiring decisions early to avoid the same fate.