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The medical device landscape is continuing to evolve as we see an increase in AI, surgical robotics, molecular diagnostics, and digital health. Even for the most traditional medical device manufacturers, the ongoing challenges of regulatory compliance, entry into new markets and keeping a harmonious balance between internal departments is prevalent.So, for the professionals working in the highly demanding role within a Regulatory Affairs team, what sets you apart from the rest in this constantly ever-changing professional landscape? What will allow you to develop ahead of schedule and continue professional development? I imagine if you are reading this and we are connected, you already have the technical competence with product registrations for medical devices, relevant academic study experience in Life Sciences or Engineering. Let’s call this the technical and core competencies.What I would like to share with you is the soft, professional skills companies are looking for. The things that start-up, mid-sized and global medical device companies are talking to me about… Every Single Day.Stakeholder management and challenging the status quo Being able to challenge the status quo, having a ‘seat at the table’ internally and being the logical, clear voice of regulatory. Clearly communicating the department wants, needs, challenges, limitations, and hard limits with regards to compliance. Replicating this externally, perhaps with suppliers or the Notified Body. Confidence is key and having the ability to be a change driver in an organisation – companies need these skills to stay innovative and agile in an increasingly competitive and challenging market. Organisational and Project Management In regulatory, unless you are in a large organisation with a clearly divided RA function, normally you will be wearing many hats and working across several areas in the business from R&D, QM, RA and auditing. Companies always have projects on-going and systematic organisation skills are key. Especially with entry into new markets and the transition to MDR and IVDR, perhaps working towards MDSAP or a first ISO13485 certification. Be sure to work on your PM skills and pick up those project leading/contributing skills. Communication skills – The ability to speak the language of engineering and regulatory This links back to point one but essentially, being able to navigate the internal structure and competing demands within the business is key. From R&D who are pushing innovation, to sales whose focus is to get the products out the door, you need to show how you handle these potential roadblocks and come to a conclusion that still meets compliance. Also, translating the data and documentation from engineering into the regulatory framework and QMS is such a valuable skill – showing that you are not only comfortable with the paperwork, but also getting a bit technical. Showcasing your listening skills and ability to negotiate with commercial acumen will gain the respect of senior business leaders who perhaps, have limited knowledge of regulatory and are in genuine need of your expert opinion and guidance. It’s not always going to be easy, but we all love a challenge, right? Working independently and as part of the team Autonomous working, especially in the post-COVID-19 remote working world is going to be so important. It was even before! Whether the company is 10 people or 10,000, medical companies need professionals who can stand on their own two feet, plan their days, have awareness of the priorities and pressures but most importantly, still ask for support when it is needed. I spend 50% of my time with my clients understanding their role requirements but the other 50% is dedicated to understanding the team, culture, environment, and people. It’s important to show you are able to build relationships with a multi-disciplinary department and be a team player towards the common goal. Resilience I will never forget the time a candidate messaged me two minutes before a call and typed “Rebecca, I have to reschedule. I’m stuck on the other line with the Russian MoH dealing with chaos!” There are going to be challenges in every day, but also variety, working with like-minded people and making a difference in the world. In interviews, competency-based assessment will be a topic. Questions like “R&D owe you a document to be able to submit a time critical submission, but they are dragging their feet and don’t see the urgency. How would you handle this situation?” This is the type of question we see come up a lot, particularly from multi-nationals and start-ups.  Dealing with organisational change, resource management, increasing regulatory pressures and interrelationship demands internally are all challenges that will bring you personal and professional growth, extremely valuable in the industry as you progress your career into a more strategic/influencing role. Your job is vitally important. You keep the medical world spinning, patients living longer and leading happier lives. There is a shortage of supply in regulatory affairs and increasing demand, but do not forget the soft skills mentioned above to set you apart from the rest!What competencies do you think are necessary for a successful career in Regulatory Affairs?

Just accepted an offer for your dream job and wondering how best to approach handing in your resignation? Please read on…If you are reading this my guess is that you have just secured a brand-new role, so a huge congratulations are in order – exciting times ahead! Obviously securing a job offer for your dream position is incredibly exciting but, understandably, sometimes that excitement can be overshadowed by the looming prospect of having to break the news to your current employer that you are leaving them.It’s almost never the easiest of tasks to give the news of your departure to your manager but as it’s an unavoidable task on the road to the next step in your career, so here are some tips to make the process as smooth as possible for all parties. Time is of the essence.This is key to you, your current employer, and your future employer. Obviously, your new company will be keen to have you join them as soon as possible and get stuck into your on-boarding process and your current employer will appreciate you giving them the courtesy of as much time as possible to find your replacement. It would always be the “dream” situation if they had sufficient time to find a new colleague who could join whilst you are still there so there could be a hand-over process and whilst this is not always possible, ensuring you’ve given as much notice as possible will keep everyone happy!Counter-offers.This is a tricky one; sometimes when you let your company know that you’re leaving them they are all of a sudden and (often all too late) desperate to show how important you are as an employee and will present a counter-offer to you. This can be tempting as, after all, increased responsibilities or earnings are always exciting but accepting a counter-offer can actually be extremely damaging in the long-term and set you back further in your career. Realistically, you were looking for a new opportunity for a reason and though the immediate prospect of a salary increase or promotion can be attractive, the long-term reality is that you’re likely to be left with regret for not having taken the new opportunity that provided you with what you were missing. Statistically, 80% of candidates who accept a counter-offer from their current employer actually end up leaving within 6 months after realising that their original reasons for looking are still valid and haven’t truly been addressed. As unfair as it may be, as soon as your company know you were interviewing elsewhere, a level of trust is often lost and your employer may be suspicious that you are interviewing again whenever you are off work. Lastly, it can also damage your relationship with the other company if you accept an offer and then retract it, putting you in a disadvantaged position if you want to work with them in the future.Honesty is the best policy.It can be tempting, and may seem like the easiest option, when asked why you’re leaving to simply say something generic along the lines of “I loved it here but just wanted a fresh challenge” and in some cases this might be true, but often there is a bigger reason behind closed doors. In reality, you are doing your employer a disservice to not share your honest reasons behind your motivation to leave as it can actually help the company to realise areas where they’re potentially not doing so well and their short-comings and how they can better support and retain staff in future. Think about what made you look elsewhere, was it down to the renumeration, lack of training or perhaps there are a lack of opportunities to advance your career? Respectfully and constructively sharing these insights with employers can really help them to improve. That said, be sure to also share everything you have gained from your time there and thank them for the opportunity that they gave to you, which leads me onto my next point...Always be professional.Sometimes it can be tempting once you have already secured a new role to let your professionalism go slightly out of the window, particularly if your reason for leaving is down to a negative relationship or unfair treatment in the workplace. This is never a good idea, namely because you never truly know who knows another professional in the industry, negative information could be passed on and come back to bite you in your career down the line so do not burn bridges and always remain professional as it puts you in the best position.Get excited!Once the task of handing in your resignation is complete, make sure you give yourself some time to celebrate your imminent new chapter! When times are “normal”, it is always a great idea to attend any social functions that you may be invited to with your new employer so you can begin to integrate with the team and get to know your new colleagues. That way, the first day will not be so daunting and there will already be a few familiar faces!I hope these tips help in some way to make the process of moving onto the next step in your career as smooth as possible. Most of all, it’s important that you don’t feel anxious or guilty about resigning – always prioritize your happiness, job satisfaction and personal/professional development above all!