hero header image Live Q&A On QA/RA/CL Careers In MedTech - PART 2 | Elemed



Live Q&A On QA/RA/CL Careers In MedTech – PART 2

On the 20th of January, we had our second live Q&A on QA/RACL careers in MedTech hosted by our CEO, Elena Kyria. During the event, Elena answered the most common questions around this topic. If you couldn’t join, click on the video to watch the full Q&A session.

Whoever said that makes a very good point. In companies, regulatory and legal typically overlap, but they are seen as separate functions. So somebody that combines both is definitely a really nice niche to be in. There’s quite a few lawyers out there that specialize in the Medtech industry and that is essentially their USP. The main thing to recognize is that the skill sets from a regulatory perspective don’t include a legal background. They typically come from R&D, marketing and even clinical. They tend to come from less of a legal background, whereas a lawyer advising a company definitely needs a legal background and it would be great to have a scientific background on top of that as well.

I did a podcast with Eric Albrecht early on when we launched our Career Diaries by Elemed podcast where we talked about the unicorn skill set of a regulatory lawyer. Check that out if you haven’t had the chance to listen to that yet.

The question really is how do you go about getting the experience? In my recruitment experience, companies always look first at a person’s experience over the background? For example, a candidate who has strong experience in regulatory and quality, but don’t have the scientific background will normally still be considered by companies. Whereas somebody with a scientific background and no experience in regulatory and quality are considered to be entry level because they don’t bring experience to the table.

Companies really look for experience over certificates only when they’re recruiting, so having experience and certificates is a benefit, but having only certificates does not help as much as you might think. So I would reframe that question to how do you go about getting the experience? It’s something I talk about a lot and I always suggest to do an internship or volunteer for a small project in between your studies just to get some experience. That would make you stand out when you’re going up against other candidates that don’t have the experience. I also recommend joining regulatory associations like RAPS, and building a network of people that you can connect with because that will help you when it comes to looking for a job.

That’s really interesting because this week we’ve had conversations with three different start-ups that are all playing in that AI health tech space. From those conversations it appears that all of these companies want somebody who has experience specifically with software as a medical device and ideally has experience of understanding how A.I. works. Companies also ideally look for R&D backgrounds in a regulatory candidate because the main stakeholder is often R&D. So if you have that background, it is generally considered that you also have the technical understanding of the products.

So I see two options. One is somebody with a deep understanding of A.I. from a development perspective and then moving towards a regulatory role and leveraging that experience. Or alternatively, a regulatory consultant or specialist specializing in software as a medical device or health tech area, as opposed to being a generalist across a wide product portfolio.

There is a lot of talk around automation replacing people, and I believe that there are areas where automation will be beneficial for companies because it makes processes much more effective, efficient, and reduces costs. Roles or activities that are very repetitive and can be automated may be replaced by technology. But equally, there are positions or skills opening up that are in high demand. For example, what’s trending right now in clinical is medical writing. Maybe parts of the literature search is done through automation or technology, but the actual writing of the reports is something that I don’t believe will be totally automated. So I recommend that you start focusing on building a portfolio of experience around roles where you still need to use scientific backgrounds, strategic thinking, and other related skill sets.

When I’m talking about medical writing, I’m specifically pertaining to clinical evaluation reports because that’s where we’re seeing a lot of growth. With the MDR and the requirements from a clinical perspective, a lot of companies need to have more people writing clinical evaluation reports and companies are doing it in two or three different ways. Either they are building out teams internally for what they call medical or regulatory writing, or they go into consultancies and outsourcing the whole project. If it’s a start up, they might give it to an independent consultant. Therefore, there is also a need for individual contractors or consultants in that talent pool. This is definitely a great area to start to develop skills and competence.

What we need to understand is how companies go about recruiting and what that process typically looks like internally. Companies often ask us to find someone locally because of the fact that their office is based in a certain city and they like to try to build a hub. From there, if we don’t find local candidates, we look in Europe because it’s easier to relocate people for permit reasons and if not, then we’ll start to look outside. The challenge is not specifically related to companies that choose not to recruit candidates from specific countries. It has more to do with the limitations that certain countries may have when it comes to stuff like work permits.

The good thing though, is that if you have a very specific experience, expertise or knowledge on a certain product that is hard to find, companies are able to build a much stronger case to apply for a work permit. So, if you’re going to look for roles like that, really understand what your expertise is and what you’re bringing to the table. Then specifically target the companies that would benefit from your specific expertise.

The other thing I am hopeful about now with remote working is we see companies offering more flexibility with where the candidates are based. The message that Elemed is putting out there to our clients is you get a much better talent pool the wider you can be. The more open you are to where this candidate is located, the more accurate you can be in finding somebody with the specific experience that you need because location is not a limitation anymore. It’s something that still needs to be improved, but I’m hopeful for the future.

Toggle ContentThe moment that you stop learning and start feeling like you’re not being developed anymore and not feeling challenged, that’s typically the time to consider a new job. And it typically always takes longer than you think. Most recruitment processes from start to end will probably take about three months on average. If it’s fast, it can be six weeks, but if a company is really picky, slow or doesn’t quite know what they want, it could even take up to eight months.

The other thing to consider is seniority level. There are typically more positions at a specialist or senior expert level out there, whereas there may only be a handful of senior director VP level that may come in a year and maybe not even in the location that you would consider. I can’t give you an exact number, but consider all of these factors and then allow yourself more time than what you think. You never want to be at the point where you desperately need to leave because you can’t stand it anymore. Always allow yourself a bit of time in case it does take longer than expected.

This is what we call a competency-based question. For any questions in an interview that’s asking you how you normally do something or what your typical response to something is, give an example. What you need to do instead of talking about how you typically would do something or how you hypothetically might do something, is to actually bring a concrete example to the table. It really speaks volumes to the hiring managers. Use the star technique or the example-based technique where you’re clearly outlining the background, what happened, how you overcame that problem, the result, and how it added value to the business or moved the company forward.

Any question that’s asking how you would normally deal with a certain situation, give a concrete example of a time when that happened. If you really want to back it up, take that example and say, “What does this example show?” It might show leadership skills, problem solving skills, ability to overcome obstacles, or ability to collaborate with different departments. Use these examples to reflect more than one type of question. That’s how you do a really effective interview prep.

Having specialisms and other areas of expertise that differentiate you will always make you stand out as a candidate. However, you have to really understand where you want to go. A lot of hiring managers would ask your recent relevant experience. So, if your end goal is to become a consultant and you plan to make a move outside of regulatory and quality with a view to jump back in, I suggest that you make sure that your Q&R knowledge is kept up-to-date and you’re still continuing to build experience in that field, not only training and certification. So I recommend some sort of combined approach.

I truly believe in always recruiting the best person for the job, irrespective of age, gender, ethnicity, etc. It is a question that makes me sad to have to answer because I really believe that if you’ve got relevant experience and you’re adding value, age should not be something you have to worry about. If you do have relevant experience in quality, make sure that you’re showcasing that experience when you’re applying for roles.

The other thing that I normally advise my candidates if they repeatedly get the same objection in interviews or applications and it’s becoming an issue, is to have a really good answer prepared for it. Don’t wait for them to raise it, but say “You may be thinking that, but actually this is the value that I bring” or “Other companies have said to me that my age is a limiting factor, but did you know that I can do or have experience in X, Y and Z? I really feel that I can help you for the next set amount of time that I’m willing to dedicate to this.”

I also know companies that would really look for the right candidate, for somebody who has a lot of experience. So make sure you’re targeting the right companies, speak to recruiters, and understand what’s driving companies to recruit those skill sets. See where you can position yourself, but also really understand what the objection is and call it out in interviews.

By consulting, do you mean working for a consultancy and being permanently employed, or taking the jump to becoming a contractor or a freelancer? If it’s the latter, I’ve done a video on my LinkedIn profile that you can watch, which is “The things you need to know before jumping into becoming a freelancer”. We also touched on this topic in the Courier Diaries podcast with Michelle Lottes, who is a consultant. She spoke about when she moved from permanent employee to consultancy and what it meant to actually set up her own consultancy.

If the question is about working for a consultancy as a permanent employee, look at that career step in the same way that you would consider any career step. For example, if you’re applying for regulatory manager roles, you might apply for roles within a medical device company as a regulatory manager or you may consider consultancy to be an option. Your experience would also be relevant in that role but they offer two very different environments. One is very much immersed in a company, a culture, a certain product, while in a consultancy you get a chance to see horizontally across loads of different companies. You build experience very quickly. You’re constantly thinking on your feet and have the chance to work on a variety of projects and products at the same time, which can be really rewarding.

We’re going to launch a poll on this actually, because this is something that keeps coming up. In answer to the question: how do you improve your CV? Number one, I recommend taking a look at our CV checklist and CV template. It’s all about highlighting not only responsibilities, but accomplishments. Too often I see people talking about responsibilities, but don’t talk about the output of what they do. How effective you are at your job is determined by the results that you provide for the company. Your responsibilities are your job role, but how good you are at your job is reflected in the results that you generate for the company. So make sure that you include accomplishments on your CV.

In terms of Linkedin, I have already launched a poll to see if people would get value in learning how to use LinkedIn to build professional brand and thought leadership. In the next couple of weeks we will make sure that we launch something specifically on these topics and make it tailored to specific job roles because that’s another big topic.

That’s a really good point because career progression isn’t only about moving up and becoming a team leader and a director. Career progression is also associated with complexity and becoming a subject matter expert. It’s really important to understand what career progression routes look like within your company? You need to engage your manager and ask what career progression looks like for someone who doesn’t want to follow a leadership route within your company. Hopefully they’ll have an answer but if they don’t, maybe it will provoke some food for thought. If there are no options and you’re going to be in that role for the rest of your life unless you want to be a manager, I suggest asking them if it would be open for consideration if you hit certain milestones.

If the company is not receptive at all, consider looking at a company that facilitates that sort of career progression. Consultancies are great for that in the sense where you can build up your competence and your seniority by working on more complex projects and managing client relationships without having to follow a leadership route in order to be promoted.

Definitely look for roles within manufacturers in the clinical department, in particular, as they really value clinical experience. Also, look at the experience that you really have. Speak to a few recruiters and understand how your experience looks in industry. Match what functions specifically value the experience that you already have, so that you can target those specific roles. Then tailor your CV and experience around the job description requirements of companies that have those roles.

Combination devices is really a specialist area. Typically, if you are from a pharma background and have medical device experience, but haven’t worked on combination devices, that pharma background is usually highly valued by companies. If you have regulatory device experience, but you want to move into combination devices, having some pharma background, qualification or training that lends itself well to pharma will allow you to leverage all that experience together to a company for combination devices. The most important thing is to understand the two different approval routes.

On top of that, there’s more complexity right now with MDR and what that means for combination devices. Stay up to date with the process as well as some of the contentious issues and questions. It’s important that you can demonstrate a clear understanding of what is actually going on in the combination space.

Elemed Mentoring Academy, in collaboration with RAPS, is specifically designed for that. It has three main pillars. One is to be partnered with someone senior in the industry and your area of expertise. That person will be your go-to impartial third person, who will help, give advice or ask questions when you need support on a monthly basis. Second pillar is a bimonthly training on specific areas focused on soft skills in order to be effective in your role. The third piece is a support network. We connect all the mentees together so they can celebrate successes together and not feel like they’re going on this journey on their own. We’ve had some incredible feedback from our mentees. So if you are feeling a bit isolated in your role or in your company, I recommend checking it out. We have an early bird offer, a discount for RAPS members, different pricing structures, and the option to pay in monthly instalments.

You can also do mentorship. It doesn’t need to be a formal mentoring relationship initially. If there’s somebody in your team who is struggling or a junior, offer to help them. Then you can ask to formalize that with your manager. Managers don’t have a lot of time so they will typically respond well to anything that makes their life easier or will facilitate the team’s success if you present it in the right way. Look for internal mentorship opportunities within the team or be part of a structured mentoring program in the company, if there’s any. There are also external programs like Elemed Mentoring Academy, where you can be a mentor and develop those skills there. Ultimately, leadership is about developing someone. So, you must have experience in building someone up, making them successful and independent or helping them to achieve certain goals.

First, make sure that you really understand the difference between a small and a large company, and that you absolutely want to make that move. Typically, in a small company you may be a bit more generalist but have more exposure. In a big company, you may only be focused on one specific activity. Secondly, apply for the roles in big companies where that small company thinking is an advantage. What big companies like about people coming from smaller companies is that they’re very hands on, able to respond very quickly to changing situations, and bring a variety of knowledge.

For instance, roles in project management are quite good. If you’ve built a quality management system before and you want to continue on with that, you may look for a role specifically within quality systems within a company. It’s about understanding your experience in a small company and targeting roles that are specifically going to benefit from that experience.

That’s a really broad question, but I did a specific video on career paths in medical devices. Also, if you are entry level and interested, I will be doing a webinar for the University of Cambridge Medtech on general career paths in Medtech, and that will be recorded and we will make it available to our network. So keep an eye on our website for that in the next couple of weeks.

It’s difficult to put a timeline on the transition. It depends on the company that you’re in as quality and regulatory are really closely linked. It might even be that you’re already doing things that are considered to be quality in your regulatory role or vice versa. So, identify what experience you already have that’s cross-transferable then leverage that in your next role.

Take for example postmarking activities. In some companies, they consider that to be regulatory whereas others consider that to be a quality activity. It will depend on the organizational structure of your company and how it’s actually considered. If you write a list of all the things that you do in your role and understand which ones are truly regulatory and which ones are quality, maybe you’ll see that you’re already doing both. Hence, that ability to leverage is going to be much easier.

For people who have less traditional backgrounds or less traditional career roots, it’s their experience and skills that others don’t have that will be valuable in the role they’re applying for. So it’s important to focus on that in an interview.

People sometimes make wrong decisions. Hiring managers sometimes hire the wrong people and equally candidates sometimes join the wrong companies. With this, it’s about just being honest. Explain that you joined the company with these expectations or intentions, but ultimately realized quickly that it wasn’t the right cultural fit. And instead of sitting in that role for years coasting, you discussed it with them and decided that it was best to part ways. That shows that you’re very clear in what you’re looking for from a company. Be open about it. I wouldn’t hide something like this. Even if you’re in an interview where they haven’t asked you that question, you can be sure that they’re thinking it. So, just like what I said about the age thing, if you think that people are having a specific objection about you or concern about your profile, call it out and address it. That way you can disarm them and they can’t continue to have that big concern since you’re upfront and honest about it.

I have done a webinar on transitioning from academia to industry, so check that out. But what I would highlight is not to apply via recruiters, instead apply directly to companies. You should apply not only regulatory and quality roles, but a broad spectrum of positions that really complement the experience that you have. Look for small companies rather than really big companies because the former typically tend to be understaffed, and more flexible in the requirements because they usually don’t have the brand that the big global corporates have. At the same time, small companies as a first experience is great because you get a more generalist experience, get a chance to go into lots of different topics and build a kind of urgency about yourself. You won’t realize you have that until you go into a corporate where everything is quite slow moving.

It’s difficult for one candidate to convince a company to change their whole policy. Typically, companies don’t like to make exceptions. This is something you need to ask during the interviews and other great questions around your main learnings during Covid. What did you learn when everybody had to work from home? How are you going to apply that moving forward? What do you believe the future will look like with regards to home office?

I think some companies that are doing it in the right way are already thinking about these things. They’ve already tried it, seen it can work, and seen its limitations. But the forward thinking companies are thinking about how they can use this, leverage it and make it better, yet still be able to access good talent. If you ask these questions and the companies say that they hated when they went remote and prefer everybody to be back in the office, then I don’t think you’re going to have much success trying to convince them otherwise.

That’s a good point because not everybody is a leader and not everybody is an expert. I think the key question is, do you love the details? If you really love the product, the challenges and getting involved in the details of what your role entails, then subject matter expert is probably the more realistic route for you to take. When you become a manager, you step further away from that. When you have a team of a certain size, it becomes about HR, and when you have a department of a certain size, it becomes about politics. So you need to have a real understanding of yourself as a person. Do you enjoy all elements of management or do you find it exciting to navigate corporate politics and influence through matrix structures? Or would you rather stay close to the detail and work on challenging projects and products? That will help you identify what route to take.

It’s a difficult one. I think it really depends on your potential, the companies that you’ve been in, and what you have achieved. Typically, the route starts with an expert and then a senior expert, which is usually at the five year mark. Here you might start mentoring people and have one direct report. Then you become a leader typically around six or seven years, but some people do it faster. If you join a growing start-up and you’re the first one in regulatory and quality, you’re likely going to be given the opportunity to recruit someone at entry level and train them up faster compared to going into a corporate matrix that has a much bigger structure. So, it depends on the classic regulatory answer.

Why would you not be interested if you’ve got to an offer stage in a process? When you get to offer stage in a process and the company has handled it right or if your recruiter managed it correctly, the only real reason would be salary or you have another offer. If you have concerns about the company or the position, always raise that much earlier on and not let it get to offer stage. But if you’re choosing between two opportunities and you’re letting go of this one, it’s important to be honest throughout the process. Let them know that you’re also considering a couple of other options so that it doesn’t come as a massive shock. When a candidate has been interested to go through the process and the company doesn’t know that they’re interviewing with other roles or that they’re not really considering to change, then you can understand that if a company makes an offer, they’re expecting somebody to accept it, especially if they’re offering what the candidate wants. Otherwise, it comes as a major shock at the end of the process and that creates bad experience on both sides. But if they already know that you’ve got a couple of offers on the table, they’re going to give the best offer that they can for you. And if it’s still not one that you want to accept, just let them know that you’ve been offered an opportunity that matches or more in line with your career goals.

I would look at RAPS for sure. They have great training dedicated specifically to these topics. Again, training is great, but you always want to supplement it with experience. So if you ultimately want to improve your career in a leadership route, you need to be working on the soft skills as well. You speak to any leader. We did a leadership roundtable for our mentees yesterday, and they all talk about the fact that to be successful in the leadership route, it’s not just about expertise. It’s about how you influence and build relationships, how you understand the wider picture, how you coach and develop people. So first, you need to focus on what your end goal is and then navigate to what you need to do in order to get there.

I think it’s all about what you can demonstrate in each role. For example, in tech people don’t tend to spend very huge amounts of time, but they work on really big projects and they can show over a two year period major impacts that they’ve had. Then it’s considered okay because of the value they added to the company. Where was the company when you joined and where was a company when you left and what did you do to move them forward? Companies prefer people that have true portfolios of experience that are varied and valid for what they’re looking for, as opposed to somebody who sat in a row but hasn’t learned anything and just counted years on their CV. Focus more on what you have achieved and what outputs you can demonstrate when you’re considering career moves and when you’re in interviews.

I do think that there are some associations that are worth being part of and looking more into. EMWA for medical writing that’s very involved in that area, so I would definitely check that out. RAPS have recently released a course specifically on regulatory writing, which I would recommend checking out as well.

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