The regulatory world has had a huge upheaval in the last few years, starting back before the COVID-19 pandemic with the publication of the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Even with the delay of the implementation of the MDR by a year, it has been an incredible drain on resources globally, often pulling the best talent within organisations into MDR transition project teams and restricting growth in non-EU regulatory functions due to budget constraints in an uncertain period for many companies due to COVID-19.
The impact on medical device companies cannot be overstated, and the resource and talent gap experienced now will be felt for many years to come. This brief article touches on several challenges and opportunities that were discussed by attendees at the recent ARCS Australia Workforce and Capacity Summit: impacts of digitalisation, remote working, competency frameworks, and pathways into the sector, and some key takeaways that I took from these excellent sessions.
Digitalisation has allowed Regulatory Affairs professionals to excel as COVID-19 prevented us all from attending our workplaces in person. The global nature of the role meant that many people in the industry were already working outside of normal hours, on calls with colleagues or regulators overseas, but potentially hampered by the uptake of technology by those they had to collaborate with.
Many businesses had to accelerate their roll-out of software to help people connect online in order to survive, and this has greatly helped fill some of the gaps in technology that regulatory professionals had experienced for some time. The result was that despite the tremendous shift in the way most people had to work, the regulatory teams around the world barely skipped a beat, and efficiencies even went up in many cases. Working from home at least some of the time was being toyed with by some companies prior to COVID-19, but a lack of trust from many managers meant that the uptake was slow. This perception has been flipped on its head in the last two years and businesses are seeing the efficiency and cost benefits of people working remotely.
The ability to work away from the office can now open up new pools of talent to fill the resource gaps the sector is facing. While historically you would have to find people in the same city as your office, or people in the right personal circumstances who were willing to relocate, this constraint can almost be eliminated. And yet the data reviewed during the Summit indicated that although perceptions were changing, many companies were not taking advantage of this yet. Working from home is one thing, but recruiting someone from a different city or country seems a step too far for most at the moment. However, the potential opportunity in recruiting remote talent is massive, and those brave enough to open up to this will reap the benefits.
The pathway into regulatory as a career is often accidentally stumbled on. Personally, I have worked in medical devices for almost 20 years, but only been working directly in Regulatory Affairs for just over two. I come from an engineering background, as do many from my team, but there are also former clinicians, pharmacists, scientists and project managers represented among us. As many of us have seen, teaching someone the regulations is often the easy part, but the hard part is finding someone with the right aptitude.
Regulatory work requires great communication, storytelling, synthesising information, stakeholder management, listening, attention to detail, curiosity, negotiation, critical thinking and interpretation, regardless of the specific regulation or technology you’re working with. People with these skills could also be very successful in a wide range of industries, so the critical question is how to attract them to regulatory. There are a few universities in Australia offering courses specifically on medical device and pharma regulations and the role of the regulatory function within these businesses, and they are proving to be extremely successful. These are great avenues for getting the word out early and generating interest so that prospective talent doesn’t just fall into regulatory, but instead leaves university knowing that Regulatory Affairs can offer a great career in a sector that is a priority for future growth in Australia. Industry’s role is also key in offering more internships and graduate placements to provide opportunities for young entries into the sector.
While the MDR has been an enormous change that we’re still finding our way through, the landscape continues to change as more countries exercise their sovereign right to create regulations to protect their people, and there will always be a career for people willing to face those changes and help businesses navigate an ever increasingly complex world.
By Steven Kennedy, Vice President Global Regulatory Affairs, Cochlear Limited
* this article was first published in Cognitio, Summer edition 2021