Medical Device & IVD Career Advice: Regulatory Affairs
An interview with Educo Life Sciences Trainers Anne Jury and Richard Young
We interviewed two of our trainers to get their views on a career in medical devices & IVDs, specifically regulatory affairs. They share their career experiences and provide some advice for those at different points in their device career. They discuss the many reasons that have kept them enthusiastically working in the sector but also highlight challenges and difficulties the regulatory role often faces. Also discussed are reasons why there is a shortage of regulatory professionals in the device industry and future trends to watch out for.
Watch snippets of the interview here:
What are the reasons for your long careers in devices and regulatory affairs?
Richard – A good question is why we stayed in the device industry. It is a really satisfying industry to work in. By working in the device industry you are contributing to the human condition. You are making things better by keeping people safe, especially in this sort of role (regulatory). I think that is quite satisfying.
Anne – The device sector has a huge variety, especially in terms company sizes. There are massive global companies, but most organisations are small. Even those micro enterprises who are start-ups are doing exciting stuff with innovative cutting-edge technologies. There is something for everyone. If you find yourself getting bored, there is plenty of opportunity to move around.
Richard – Absolutely. There is always a lot of room for good people in the industry. Especially as the medical device sector is viewed as the poor relation to pharmaceuticals. Over the years it is a prevalent position and there may be some truth to it. But I think it is it is a very vibrant industry.
Anne – I think that’s true in regulatory terms. It is still seen as the poor relation to the pharmaceutical industry and it really isn’t. It is, in some ways, more complex because of that variety of technology involved.
Richard – Oh absolutely. In my role I provide support on a variety of products. For example, I could be dealing with a tongue depressor one day and an MRI scanner the next day. The range of products that fall under devices is huge. Examples include drug device combinations, companion diagnostics, and nanotech.
Anne – As a consultant, I am constantly surprised by questions I am asked by companies that I have never thought of before. Or a scenario, product or conundrum that I have not seen before. There is never a dull moment.
Richard – Yeah, I agree completely. Even now I am amazed by some innovative ideas by start-ups. People approach me with a great idea and explain how it is going to work. You step back and think wow, that is genuinely exciting.
During your careers how have you seen the device industry, specifically regulatory affairs change?
Anne – I do not know that the industry has changed an awful lot. In technology terms, it is innovating constantly. One thing that occurred to me during my career is that devices came from other industries. The division I first worked for at Smith and Nephew was textiles. It had originally been founded to make denim for sailor’s uniforms and now they made wound dressings. This trend was the same in other sectors that morphed into devices. You have got the steel industry, you have got textiles. You have got electronics. It is therefore an industry that is used to constant change.
What are the challenges of a career in medical device regulatory affairs? What should people be people be prepared for during their careers?
Anne – You really must have an extraordinary amount of patience. You also need to have high level of attention to detail on everything. We have got a regulatory perspective so what we say in training courses so often is “if you didn’t document it, you didn’t do it”. It does not matter how great you are at your job, you must leave that trail of evidence. Like Richard said before, it is all about patient safety and improving lives. You are responsible for that interface of your product with the patient. So you’ve got to have that attention to detail as well as a good deal of common sense. People think the regulations are just something to follow, but actually it requires a great deal of interpretation.
Richard – In a lot of smaller companies, the person with the quality or regulatory background is often the only person in the company who is championing the importance of following the regulations. You must make people realise it is not just a box ticking exercise, constantly pushing the regulatory agenda to ensure the continued success of the company.
It can be very frustrating having to convince others in your company of the importance of regulatory affairs. You need the softer skills to bring people with you and get ‘buy-in’. Therefore, the regulatory role is not just about technical knowledge. You must be able to communicate and ensure the wider organisation appreciates the role of regulatory affairs. You must make sure those regulatory requirements and goals are met by the company.
“You must be able to communicate and ensure the wider organisation appreciates the role of regulatory affairs”
Getting the regulations and the documentation right is half the company output. You can have the best product in the world but if you have not done the regulatory work well and you fail to maintain it going forwards then you will fail. That maintenance is important. You have got to get your product to market but that is often the easiest part. Staying compliant is the challenge for a lot of companies and you could be the only voice yelling in the darkness about that. It is liberating, but it can be a bit of a challenge as well and something you need to master.
It seems, especially in smaller companies, a big part of the role is managing upwards. You must convince management of the importance of regulatory affairs and how important it is to the success of the company.
Richard – Absolutely your skills managing upwards, sideways and in all directions are important. Those soft skills are an important skill set of anybody working in this role. Integrating the technical with the softer side is important for success.
I do not know of a role in any industry that gets into so many areas of the business. In regulatory affairs you are working with all departments. You work with sales and marketing to make sure that they are working within the system, sharing information. You are working with operations. You are working with logistics. You are working with finance to make sure that all comes together.
You should be integrated with everything. That gives you such a wonderfully broad view of an organisation. If you want a broad exposure to all the elements of a functional organisation, I cannot think of a better role really.
“If you want a broad exposure to all the elements of a functional organisation, I cannot think of a better role really”
What would be your career advice for those starting in device regulations?
Richard – I am going to steal from Douglas Adams and say do not panic. There are a lot of resources out there such as LinkedIn and the internet. The internet is a great resource that will provide you some insight and guidance to the role. Make use of experienced colleagues around you. Do not panic and make sure that you have a good understanding of your organisation and what it is making and doing.
“There are loads of companies looking for those younger staff to recruit and educate them in their technology”
Anne – I would add to that too. You want to know yourself, what you are good at and what you like. It does help to know yourself, because otherwise you could end up in a role or doing something that you were pushed into. In regulatory affairs, that can happen quite easily. There are not enough regulatory people out there. There are loads of companies looking for those younger staff with an aptitude for regulatory affairs to recruit and educate them in their technology.
What would be your advice for those with more experience in their career?
Richard – You are going to be getting out and branching out and maybe being more strategic with the company and supporting wider business goals. You will likely be involved in more policy development. At that point it is a good idea to spend some time upskilling in general business techniques and management. Especially if you have a technical background like me in life sciences.
Anne – That fits with what you were saying before about soft skills. You know you need to develop your soft skills at that stage. If you are in it for the long haul, then you need to start pushing and not just reacting to things. There will be times as a regulatory person you have to be the one to highlight certain issues or concerns.
Richard – You have got to transform yourself from a contributor to a champion. You need to take those technical skills and start applying them more strategically by planning.
What would be your advice for people as they progress in their career?
Richard – I think when you get to the more senior levels, I think there are decision points that are going to come up. It becomes more about managing who you are and what you want out of that point in in your career, in your life.
For example, a VP of Quality and Regulatory of a big company. They will have a really demanding job. It will take you all over the world, however you will be working long hours. It is a full-on commitment to work. Depending on the size of the company you are working for and you have got to be happy with that.
Alternatively, working with smaller companies is a good way of taking your experience and sharing it and the demands may be a lot less. You can also participate in things like industry forums.
Anne – You can also get involved in standards committees. Or organisations like medical device technology trade associations. They can be quite fun at that point.
What would your advice be to those considering a career in consultancy?
Richard – I think at any time in in your career you could consider moving out into the consultancy field. In my experience, the successful consultants who regularly get the good work are the ones who have got the background and experience they can take to their clients. They can offer decades of experience that they can be bring to problems.
It is very different being a consultant than it is working in a business. It is very rewarding from a different perspective. You see a lot of companies and a lot of technologies. However, you are sitting in your home office by yourself, for long periods of time and you really need self-motivation, time management, focus and organisation.
Anne – I think there is plenty of room for consultants in this industry as you need all sorts of skills. I work very much with a group of colleagues and we all have different niches.
Richard – There is a large, flexible market for flexible working within the device industry where people are brought in across a series of disciplines. Contracting for specific projects for 6-to-12-month periods of time, very successfully.
There is a shortage of people in regulatory affairs. Why is there a shortage and what would you say to people considering it?
Anne – I think there is a shortage because people do not really know about it as a career. Quality engineer is a well understood role. When I first started the roles would be separate. The regulatory people did not sit in the same office with quality people. Now they are all together and doing bits of both functions. So, it is perhaps a little better understood now, but I still think there is a lot of people who do not know that is something to apply for.
“I recently read an estimate that there is a shortfall of 2,500 positions across Europe in technical quality regulatory roles”
Now there are more courses out there but geared towards device development. Then out of that comes a recognition that we need to understand the regulations a bit better. So those with the aptitude for reading and remembering stuff go down that avenue.
I think the other thing is that companies should try to think flexibly. I think there probably are more people out there who might be available to go to some sort of part time work. The shortage I see is around the university spinouts as they are mopping up everybody that exists all the time. They then create a local shortage. If they think more flexibly, they could include part time workers.
Or what I often do as a consultant is help them on the way. I create the regulatory and quality strategy and then advise on the people that are needed. They then bring in a junior person who I can then mentor, making sure they do not miss anything key and that works well.
Richard – I recently read an estimate that there is a shortfall of 2,500 positions across Europe in technical quality regulatory roles. That is split across notified bodies, whose work is expanding, and industry. We never had a huge number of people working in these regulatory roles before the latest regulatory changes (MDR).
Also, within medical devices you never see huge departments. A lot of the more senior people who were the sort of the pillars of the of the profession have left and retired. For a long while there were not enough people maturing into those senior roles. Succession planning was not going on across the industry. It happened in certain companies, but not across the device industry. So, there is a shortage of high-level experience across a lot of organisations.
Another issue going back to universities. There is no career day at university showcasing medical devices or courses that map out a career in regulatory affairs. As a result, there is no clearly defined career pathway.
What are the exciting or growing areas in devices over the coming years? What areas should professionals be keeping an eye on and looking to move into in the future?
Anne – There are technology areas with certain product types are growing. The two that come to mind in my head instantly are software and artificial intelligence. There is also a growth in biotechnologies such as tissue engineered products. Also, more combination products as well.
“The regulations in those cutting-edge areas are interesting and extremely challenging”
The regulations in those cutting-edge areas are interesting and extremely challenging. For example, the use of artificial intelligence and machine learning is cropping up all the time. The regulation does not address that AI and machine learning so how do we regulate for that? The more people that get involved and get onto the committees the more you can help to shape it. That is an area you can get involved in, and the same with those combination product areas. There are loads of working groups and committees to help shape the regulations on that sort of thing.
Richard – Anne is right about the regulations and the standards do not know how to handle big data and AI. I have some experience of a few AI projects such as breast cancer scanners. And they all do the same thing. They spent a huge amount of money developing these vast databases and learning algorithms to predict stuff. And it is all absolutely cracking. And then they will say, obviously this is just for advisory purposes only. This is to triage and it must be looked at by a professional. They do this to keep the classification and the focus on the core intelligence of software to a minimum. Ultimately it keeps the regulatory scrutiny down. If they say it can diagnose a cancer, it goes up a level in regulatory terms.
Richard – The other one I see is the nanotechnology area such as surface finish and nano finishes is going to be very interesting.
Finally, another thing that excites me on a regulatory level is that we are getting a lot closer to a global regulatory system. A basic globally agreed regulatory system. We are shaping that at the moment with initiatives like the MDSAP initiative. People are gradually moving into a common way of working. That is truly exciting as it makes technologies available across the planet, improving access to patients.