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Live Q&A on QA/RA/CL Careers in MedTech

From a short term perspective, the MDR and IVDR are generating positions that are contract/time-limited roles. They’re normally short-term freelance consultant type projects and companies look for people who are able to do the hands-on work such as remediation and documentation in order to comply with the new MDR. But in the longer term, after the date of application actually comes, there is an increased demand for predominantly permanent roles.

If it’s your first job in Medtech, I always suggest going specific on your area of product expertise but staying broad in terms of the type of role that you would apply for. If, for example, you have a specific background in nanotech or biomedical engineering but you’ve got a specialization in orthopaedic devices, and you’re looking for your first role in Medtech, always go for companies that specialize in those types of products and apply to it to a broad variety of positions within those companies.

Don’t only look for let’s say regulatory roles, but also look at stuff in clinical, quality, development, product management or within the area of expertise that you’ve specialized in because these companies are going to value the expertise that you’ve studied. There might also be positions that suit your knowledge but you just haven’t thought about.

Companies will always hire for experience over professional qualifications if the professional qualifications are not mandatory in order to do a certain role. That said, to stay updated about the new regulations I recommend joining an MDR group such as the one we have on Linkedin that I hope some of you are members of. That’s where people share breaking news, ask questions, help each other and give their own interpretations of certain parts of the new regulations.

In terms of courses to develop your experience, I definitely recommend the trainings offered by Notified Bodies because they’re the most highly recognized. BSI and TUV have very good training courses on different specific areas of regulatory, quality and clinical topics. RAPS is very well known in regulatory affairs and their content is highly recognized as well.

Keeping up to date is more about being fully immersed whereas doing courses is like supplementing your knowledge. So I also highly recommend going to events, even virtual events, in order to really keep up to date with what’s breaking and what’s not.

This is a really interesting question. Culturally, some countries use cover letters more than others. But a few months back I surveyed 151 hiring managers and specifically asked them: When you receive a candidate’s application, do you look first at their CV, their LinkedIn, or the cover letter? Of the 151 hiring managers, 72% said that they open the CV first. 17% go straight to LinkedIn and only 11% read the cover letter first. This was absolutely critical because it shows that people open the CV first before the cover letter. As a recruiter, I also do the same thing.

The most important thing is that your CV is clearly reflecting your experience and suitability for the job. You should tailor your CV per role that you’re applying to. If there’s a specific type of experience that a position is looking for, it needs to be clearly seen in your CV. Having a general CV and then just mentioning that specific experience in your cover letter is not enough because people are not necessarily opening cover letters. 

Some candidates also write their cover letter in a story format. However, the cover letters that are the most effective are the ones that say “Dear Hiring Manager at company X, I was interested in this role because I have this experience that you require over this period of time. These are the projects that I’ve worked on that are specific to what I know you’re looking for and this is where I feel like I personally would be able to add value to your position.”

When it comes to LinkedIn, make sure that it’s up-to-date and clearly reflects whatever you have on your CV. Although it doesn’t need to have the same level of detail, the positions have to be consistent. We had a candidate once whose CV had fewer positions than in LinkedIn, and the job titles did not correspond. They looked inflated on LinkedIn, which the hiring manager picked up on and thus didn’t proceed with the candidate. So, it’s really important to ensure consistency across your messaging.

It’s best to do both. What I really like to see on someone’s CV are clear competencies, not soft skills as these are subjective. Someone who you think is really proactive might be really pushy for someone else. It’s all a matter of perspective.

Always try to keep your CV factual and based on things that can be proven. I like to see key competencies in terms of experience. If we’re talking Regulatory, do you have experience in CE Marking? What risk type products have you worked on? What geographies have you covered? Have you worked on new product development? Have you worked on post-market activities? In your actual career, your job title and your responsibilities are essentially what you’re supposed to do on a daily basis. Whereas your accomplishments are how well you do your job and how effective you are at your job. So definitely indicate your responsibilities but also put in your accomplishments in your CV.

If you’re able to collaborate on a project with clinical and quality, have a conversation with your peers and understand what you love about your job and what you always wanted to know about Regulatory. Have a conversation to learn a little bit more about what their role is.

It’s also great to have a chance to volunteer in helping them with something that they’re working on so that you can start getting a little bit of experience. Then you can supplement it with the training and maybe transition into a role like that later on.

As soon as you know that it’s a career that you would want to pursue. It could be your first job or you could come first from areas outside of Q & R then you move to regulatory. The right time is as soon as you’ve decided to pursue it. It’s never too early or too late.

We recruit these roles all the time and when we ask VPs and directors, the one that comes up over and over again is problem-solving skills. Are you somebody who is able to come up with different solutions for problems?

Attention to detail is also a big one especially if you’re working in regulatory. The ability to understand the big picture is also interesting for small and medium-sized companies. Having a good understanding of how your role actually fits into the bigger picture and a curiosity to learn are really important.

From a technical perspective, having a background in that specific product that you’re working on or a background in the Medtech industry is important to understand what you’re operating in. Without that, some education and/or hands-on experience in quality and regulatory, even if it’s just an internship or supporting role in a project, are also really highly valued.

This is a really interesting one and I always say to people to make the move when you stop learning or when you stop feeling challenged. I truly believe that you shouldn’t stay in a role that you’re unhappy in or where you’ve stagnated just to collect time on your CV. The question is, do you have five years of experience in company X or are you repeating Year One five times over? If it’s the latter, then you’re not actually learning and growing.

If you get to a point where you feel like you’ve stopped learning, the first thing you need to do before looking for other opportunities is to address it internally. I’m a big believer of always going internal and saying, “What else can I do? I want to transition or pick up more projects. How can I do that?”. Know what the next step is, address it internally, and then you know where you stand. If the response is negative or you have no options to progress, then start to consider external options. But always try to address it internally first because if your company values you, they will try their best to keep you by offering you other opportunities or projects.

Although there are new position titles in regulatory, quality, and even in clinical, we don’t really see a consistency in job titles. For example, because of Brexit and other countries leaving the EU, some hot titles are the PRRC and this UK responsible person. I think it’s more about understanding the new responsibilities and not just the titles.

The classic titles in areas around Post Market, clinical, and medical writing, will also have new responsibilities. Roles in regulatory, combination devices and IVDs are also hot areas with real growth.

From a business perspective, I understand why companies use these online tools and platforms. It creates a streamlined workflow and allows companies to see where the candidates are coming from. But from a candidate’s perspective, the amount of friction that it creates is huge. The dropout rate of candidates applying for a role is high because after spending a lot of time creating their CV, they still have to recreate them on online forms and upload a lot of information. That is a tedious process. And I can’t tell you the number of companies that we’ve worked with that use automated software systems yet still don’t find the right candidate because it’s being done by a keyword search.

Sometimes a candidate can beat the algorithm but it doesn’t create a good experience. When we purchase something from a shop, we want a good customer experience. So I’m all about companies trying to create good candidate experiences as well. That means no friction, giving personalized feedback, and actually getting back to people, which these automated systems don’t allow. Unfortunately, you can’t get around it with big companies. The best thing to do, if you are being represented by recruiters, is have a relationship with the company as there’s usually a fast track route to make sure that your CV doesn’t get lost in a black hole.

It’s always the experience first supplemented by education. If we apply it to quality, careers have become more specialized in a certain type of quality such as product quality or quality management systems or even simply focusing on auditing or training. You can either choose to specialize in a part of quality or you can specialize in a certain size of company. I see great opportunity for somebody who is a generalist in terms of the type of quality, but specializes in start-up companies or companies with less than 50 people. Their needs from a quality perspective are different to that of a great big multinational.

I believe in building up a portfolio of experience throughout your career whether you are perm or a consultant. Always add to this portfolio of experience because that is what companies usually look at first. They will look at your qualifications first if it’s absolutely mandatory for the job. Then they will look at what experience you have specific to what they are looking for and how you can best help them.

First of all, you have to understand what you’re shooting for in the long term. Where do you want to go? Do you want to go into the corporate leadership route? Do you want to become a senior expert? Or do you want to go self-employed in the long term? Once you’ve chosen out of these three options, then this question can be better applied because there are pros and cons to both. The leadership route, especially in a big company, provides more opportunities to potentially move upwards the career ladder, while the self-employed route prefers people who have broad regulatory and quality experience.

When you’re working in regulatory in a big company, you might be focused on one specific country or one aspect of regulatory affairs so it might not lend itself so well. On the other hand, if you want to be a senior expert in regulatory affairs but working for multiple different companies as you transition through your career, then working in a big company where you can really go deep, adds value. First, start by understanding where you want to go long term and then reapply this question.

First of all, is this the route that you want to go? If the answer is yes, then you have to understand the role you’re applying for and assess whether you have the specific experience that will be valuable for a large corporate company. If you’re working in a startup, you typically have the ability to flex really quickly because things are dynamic in startups all of the time. You also tend to have a broader experience but on fewer products. For instance, you’ve jumped into a bit of quality and regulatory but only on one specific product type. So how can you apply that in a specific role at a corporate company? You need to look specifically at the requirements then match up your experience, and make sure it’s clear on your CV.

Problem-solving skills, collaboration from a soft perspective, being comfortable in gray and new areas, and finding out answers to certain questions. Technology changes faster than regulation. Inevitably, especially if you’re working in the software of a medical device area or anything that’s quite high tech and fluid, you will very often find yourself in situations with no precedent or you don’t know the answer. So you have to be comfortable finding answers to problems that you haven’t worked on before.

From a technical perspective, companies have started choosing specialists type of experiences such as experience with class three devices and new product development projects. The admin side of regulatory may also be automated in the future. Technology can be applied to administrative tasks that don’t require problem-solving skills to automate the workflow. So start focusing your experience on new product development projects and those involving innovative technology to really build up that portfolio of experience in new areas.

The medical device industry is big so let’s apply it to the role types that we’re talking about here. From a quality perspective, auditing and experience around 13485 are obviously big. From a regulatory perspective, companies are very interested in people who have experience with new product development projects, MDR/IVDR implementation, CE marking, 510k, and market experience with specific regions and countries. From a clinical perspective, medical writing, clinical evaluation reports, and clinical study managers running the clinical ops side of things are in demand. From a quality management system perspective, building up a QRA message from scratch is what a lot of startups look for especially if you are a consultant or a freelancer.

Well, a manager in regulatory and quality is one of these titles that doesn’t really mean much because it could be a project manager, a senior specialist that is called a manager, or a team leader. In the concept of team management, companies will always look for leadership experience. But there are some myths in the industry and one of them is
“we’re all fishing in the same pool”. This isn’t totally true because Notified Bodies don’t really fish for regulatory people. They fish more for R&D people. And there is this sense that a lot of recruiters will contact you once you’re at specialist level and that there seems to be a lot of jobs out there. But when we last looked at the stat, for every one person there were six roles at a specialist level. At a manager level, the competition significantly increases because a high percentage of specialists want to become managers. Unfortunately, there’s not that many leadership roles and the higher up you go into the pyramid, the less roles there are and the higher the competition there is. Hence, companies have the luxury to choose amongst people with leadership experience for leadership roles.

What if you’re looking for your first management role but you don’t have any leadership experience? Try to get the experience internally first if you can and then transition outwards. Companies are less likely to take a risk because when they hire someone, they essentially risk hiring somebody that they don’t know, has no leadership experience and needs total training, and it might not work out. If a company has a choice between hiring somebody internally and training them on leadership and hiring somebody externally with no leadership experience, unless there’s absolutely no opportunity internally, they will usually hire internally rather than externally. You always have an advantage over external candidates if you can put yourself forward for leadership roles internally.

The most in-demand skill set for consultants is hands-on ability. When companies go to consultants, they want people who can actually do the work as opposed to doing the strategic stuff. When companies go for Strategic Consulting in quality and regulatory, they’ll normally choose the people who they already have relationships with making it quite difficult to only target those roles. So it’s better to consider a wide range of positions. Ones that allow you to be hands-on and then build up to doing more strategic work for a client. If you are already a senior consultant and prefer not to do the hands-on work, perhaps look at interim positions as well.

In terms of quality and from a leadership perspective, companies tend to choose between those who built their team versus inherited their team. Actual experience of building up a team is valued more than inheriting a team and never recruiting or developing anyone within it. For the executive leadership level, companies look for remote leadership. Are you able to manage locally and across multiple geographies? Are you able to manage across multiple different leadership levels? Managing managers and multi-site responsibility are also something that I highly consider for the V.P. roles that I recruit for as these are the key things that companies look for.

No. Your LinkedIn profile could be your online CV but it’s a little bit more generalist and the purpose is different. The CV should be tailored for each specific role that you apply to. Knowing that 72% of hiring managers will go to the CV first and then might go to LinkedIn, always have the majority of the detail in your CV.

They’re kind of different things. The roles that LinkedIn will show you will be based on the amount of detail that you put on the job titles on your LinkedIn profile. You can also set up job alerts. For example, if anyone follows the Elemed company page, you can set up alerts that will notify you via email whenever Elemed posts a new job. This doesn’t really depend on how much detail you personally put into your LinkedIn profile. When you’re doing easy apply, which is to apply for the role, you can essentially just put your name, your job title, and your phone number. But then I would question how many candidates that hiring manager may already have. If you don’t attach your CV when you do easy apply and you have little information on your LinkedIn profile, there’s a chance that they don’t call you if they already have a lot of candidates and/or they have a priority list, or maybe you’re contacted as a lower priority. Always try to do a full application when you can.

I’m going to give a regulatory answer, which is it depends. But generally, being able to interpret data is important. It depends on the way that the company structure or how the role of writing clinical evaluation reports is done. Some companies will actually split the role and two or three people might write the CEO giving you more flexibility. But if you’re writing the whole thing, you really need to be able to interpret the data if there’s no one internally that’s able to do that for you.

Yes, because some people are working remotely and you can’t always reach them when you call the general company number. This is the benefit of being represented by a recruiter who will do the chasing for you when chasing needs to be done. If you have done a direct application, it’s more difficult because on the one hand, you don’t want to be that pushy candidate, but on the other hand, you don’t want to be ghosted by the company. What do you do in that situation?

I recommend doing two things. Number one, at every single point of the interview process, always ask what the next steps are, when they will most likely make a decision or when you can expect to hear back from them. If you asked that at every stage of the process and the company doesn’t commit to what they’ve said, it then gives you a reason to follow up. That’s number two, send an email to follow up on your application. If you work with a recruiter, just push on your recruiter. If your recruiter is doing a good job, they should already be asking these questions on your behalf to the hiring manager. Although things don’t always go to plan and sometimes recruiters get ghosted, in most circumstances, they should be able to give you an update of the timelines.

If you have a specific type of product experience, look at the companies where that experience would be interesting. Start with those companies and apply for a wide variety of positions that they have at the entry-level.

First, try to understand why you’re finding it difficult to find a job. Is it because of Covid that has had an impact on the job market, or is it because you’ve had these career breaks? Try to ask the companies that are giving you negative responses to really understand the reason behind that. If it’s COVID, then, unfortunately, it’s about timing. Consider increasing or broadening the things that you’re applying for. But if it’s because you’ve had this gap, make sure that you’re highlighting your experience that’s relevant for the role that you’re applying for. Also, consider doing a short project just to get back into working on something that’s current for a company. Use that project experience, even if it’s temporary, to leverage into a permanent role whilst you continue making applications.

Start by understanding where you benchmark in the industry. As opposed to just making up a number, have a look at our salary report. We did a really detailed report earlier this year specifically on what the market rates look like. Start with that and use that as your data point if you’re having a discussion around a promotion or other internal use. We’ve had candidates that have taken that to their managers and have had positive outcomes.

If you’re negotiating salary for a new position, be really clear upfront. When initially applying for the role, clearly state what your salary expectations are and then be quiet. Some people spend too much time talking when it comes to expectation and then talk themselves out of it in the end. Be quiet and see what they say. Don’t go into saying, “but I’d be willing to negotiate twenty thousand here or there”, because then you’ve automatically told them that you would accept 20k less than what you’ve just said. Don’t undo what you’ve already said. It’s about being upfront and honest. At the same time, don’t dramatically increase your salary expectation at the end of the process because that kills trust. While companies shouldn’t lowball offer candidates, candidates shouldn’t be hitching up their salary expectations in the end as well. It’s about being clear from the beginning.

I think it depends on the type of role that you’re applying for. In medical writing, it is highly recommended and valued. In regulatory and quality, it’s nice to have but not a must. The first thing is to really know if you want to do it and if it adds value. If it’s personally something that you want to do, go for it.

When it comes to being overqualified, a lot of the time companies don’t really mean a candidate is overqualified. What they mean is the salary expectation is too high. Sometimes what we find are people that have just finished their PhD and have zero experience. They’re looking for their first role from academia into industry and they might have higher salary expectations than people that already have two years of experience. So companies might use the excuse that a candidate is overqualified to mean that they don’t have enough experience for the salary that they’re asking for. Companies don’t really turn down candidates with high qualification, experience, and salary expectations that are in line with what they’re offering.

You have to understand that having a PhD might mean that you earn more money later on in your career, but not necessarily at the entry-level. If you are okay with that and you’re able to pitch at the right level, then definitely go for it. It’s also good if you’re able to build a little bit of experience while still doing your PhD. I did a really nice Q and A on moving from academia to industry. You can check that out if you want more information on that.

Medical devices companies, specifically on elective surgeries, were impacted across the board. But IVD companies, as well as those in the ventilator or the PPE space, are doing a lot of hiring. Not so much role growth in quality and regulatory, while more on the production side for clinical. We also saw that in Q1, Q2 of this year, companies took longer to make decisions so hiring processes were a bit longer than in the past.

However, last month was actually our busiest month for new jobs despite everything that’s going on with Covid because MDR and IVDR are coming next year. Perhaps companies have also figured out how they’re managing remote working, so now that they’ve already laid the groundwork, they’re pushing forward because the future is uncertain and they need to hire these roles. There were no dramatic job losses like we have seen in other industries which is really good to see.

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