Blogs

Dealing with conflict or tough conversations at work. It’s comparable to the ‘we need to talk’ dread all of us have undoubtedly faced at some point in our personal lives.Whether it’s addressing distracting behaviours in the office, challenging your colleague on the accuracy of a report or confronting a long-overdue company problem – these conversations need to happen, and they need to happen for a few reasons:-         The problem can’t be fixed if there is no awareness of the problem in the first place.-         Get that weight off your shoulders, its liberating!-         It’s how we achieve professional and personal growth – your company will benefit from this too. The art of conversation is like any art. With continued practice you will acquire skill and ease.Finding the right words, and the right moment – it is no easy task in the fast-paced commercial world. Step 1) Conquer your fears and just do it.Here are some tips to make the conversation easier…Set a Positive Tone -         Mindset matters. Frame the conversation in a different way and put a positive spin on it. Be constructive, not negative. Can you offer an alternative solution to the one currently on the table? Make sure there is an action plan in place when a consensus (or even just an understanding) is reached to ensure you move forward.Keep Your Cool-         Don’t forget to breathe! Taking this brief moment to focus on your breathing will allow you to refocus and absorb any information. It’s important that whether you are the recipient or provider of a challenging discussion, that you make a conscious effort to slow down the pace of the conversation, listen, collect your thoughts, and respond rationally.Plan with Emotional Intelligence-         Think ahead. What do you anticipate the response will be to the discussion? Put yourself in the shoes of your counterpart to mentally consider their possible responses. You can have some flexible strategies to hand on how to move the conversation forward in a productive way. If you don’t feel confident on the recipients view beforehand, ask them.Be Concise and Direct-         Difficult conversations need to be clear and to the point, otherwise the message gets lost in a muddled delivery. To avoid receiving objections, be prepared with concrete examples. Focus on facts, not feelings. Try not to let your emotions get the better of you when you are trying to find a resolution.Make It a Conversation-         Feedback shouldn’t be a monologue - there should be two-way communication. Make sure there is an opportunity for an open discussion and questions to allow the meeting to end with unwavering clarity on both sides. Do you fully understand each other and what will happen next?  “Difficulties are meant to rouse, not discourage. The human spirit is to grow strong by conflict.”- William Ellery Channing, American Theologian

Building ResilienceResilience is the capacity to recover quickly from difficulties. So, what can we do that promotes resilience? AcceptanceWe must accept that stress, mistakes, and failure are an inevitable part of our everyday, in our professional work and in our personal lives. Adversity does not discriminate, we all have to handle situations in life of challenging pressures at work, grieving for a loved one, conflict in relationships or mental illness. The list goes on…The saying ‘failure is not an option’ is redundant in today’s emotionally intelligent world. Resilient people know that sh*t happens.In case you were thinking about boxing up all that stress, worry and, pressure - suppression is not an effective strategy. Try not to think about something, and guess where your mind goes… The ability to make mistakes, learn from them, and rebound is resilience building and from this we can branch out into new directions, boost our immune system and lead happier lives. Run Towards Resilience By taking opportunities for change and personal/professional development, we learn how to handle failure, rejection, mistakes; how to rebound and recover from extraordinary circumstances.Build your resilience by making pursuits meaningful. Meditation, photography, learning a new language, taking that course, asking for more responsibility at work…Be kind to yourself by discovering enjoyment in the challenges you face and be optimistic, even on the tough days. By finding your inner drive to take on new projects and also keeping in mind your future focus, you’ll be more autonomous, pragmatic and nurtured as a person.  Stronger and more prepared for whatever comes next in life. Mindset Matters Slow and gradual behaviour change is more likely to last. Commit to a manageable behaviour change and we are more likely to follow-through. Balance this with self-compassion.Exercise is so good for us, not only physically but for our mental health and to build cognition. Aim to do a walk for 10 minutes a day over lunch but always show compassion to yourself. If you are too self-critical when you miss one day, you are less likely to bounce back the next day.Be careful of when you place your attention.  As humans, our survival instinct makes us excellent at noticing weaknesses and threats. Take a step back, is the way you are thinking going to help you, or just have a detrimental impact you?Resilient people make a conscious effort to not be swallowed up by the negative and instead focus on benefit finding, all those things in your life that you can be grateful for.Don’t do it aloneMake a deliberate effort to find what’s good in your life. This should include a strong social connection with colleagues, friends, and family who you can turn to in your times of need. Resilient people ask for help when they need this and see this as a sign of inner-strength, not weakness. What changes do you need to make in your life or your mindset to become resilient? 

I want to talk about criticism at work, how to take it, learn from it and move on.It is one of those factors, that un-FORTUNATELY (yes- you read it right) is ever present in our professional lives, and I for one am happy about that.However good we are at our jobs, however efficient and hard-working, there’s always room for improvement.… But how could we improve if we don’t think we need to?Just like Winston Churchill once said:“Criticism may not be agreeable, but it is necessary. It fulfills the same function as pain in the human body. It calls attention to an unhealthy state of things”Even though we all know that constructive criticism is more useful than a praise, I’m sure some of you would agree that being on the receiving end is not always easy.To help, I’ve put together a few tips:First, be open minded. Show your supervisor that you are open to receiving the feedback, why? Managers as well as clients also dislike giving criticism, so by saying that you are open to it, you prove your mental maturity and help to build a better rapport with them for future.Second, listen. Take it all in. Do not feel like you have to respond immediately. You want to show that you have listened, are not defensive and are accountable. Make sure to thank them for the feedback and let them know you appreciate it.Afterwards we might feel bad, embarrassed or even angry. That’s absolutely fine – we’re only human. Call your partner, friend or a close colleague and acknowledge your feelings. Then once you settle down you will start to see the situation in a new light.Third, learn. Try and find a lesson in the criticism given. Now that you had time to digest what’s been said, see what you can take from it for future improvements. 8 out of 10 times, negative feedback is given in order to help you develop and grow.Fourth, move on. Nothing more, nothing less. Once you’ve been given the feedback, you acknowledged your learning or reflected on the mistake – move on.The reason for giving you this feedback in the first place was not to put you down and make you feel incompetent – it is to ensure, that you improve and grow!

“Self-care has become a new priority – the revelation that it’s perfectly permissible to listen to your body and do what it needs.” ― Frances Ryan Burnout - lets talk about it!It’s one of those subjects that often gets mentioned, but never really discussed. I think it’s time to change that.I am actually quite surprised that in today’s day and age it has not been classified as a medical condition yet, because let’s face it – it is.Burnout is very popular and happens more often than people would like to admit. It’s that state of mental, physical, and emotional exhaustion, caused by prolonged, work-related stress. In order to come up with ways of avoiding it, let’s break down the definition to see how each of the factors can be FIXED!Emotional exhaustionEmotional exhaustion is a state of feeling emotionally worn out and drained. This can be easily improved by ensuring we eat right, take technology breaks, meet with our friends, and of course exercise. Yes, many people could argue that exercise is a suggested remedy for almost everything nowadays, but in this case it is true. Exercise releases chemical endorphins to the brain which triggers a positive feeling in your body. So there, we have proof that going for a run or taking that HIIT class is worth it!Mental exhaustionMental exhaustion is similar, but the symptoms can be more severe, as the person experiencing this feeling starts to be detached, showing apathy towards their work colleagues and the work itself. The first thing to do if possible is to remove the stressor. If it is an overwhelming task at work, perhaps speak to your Supervisor – see if they could offer you some help. Don’t feel that you have to go through this alone.Again, try to eat well and stay active, but also practice relaxation techniques like yoga, massage, or mindfulness – all scientifically recognized to lower stress and anxiety.Physical exhaustionPhysical exhaustion is an extreme state of unrelenting fatigue and sometimes it can be brought on by the previously mentioned mental exhaustion. Being in this state can cause dizziness, chronic tiredness, and headaches, which if untreated can lead to moodiness, slow reflexes or even bad judgement/decision making.Get some sleep! Clocking in your 7 - 9 hours of sleep a night can restore well-being. Set aside some time each day to stretch and try eating foods that improve your energy level, like nuts, fish, and cheese. Magnesium is an essential mineral to promote a healthy nervous system, energy production, and for muscle relaxation.Also, if you ever notice that someone around you is starting to display any of the above signs, see if they are ok, offer them help. Trust me, it will make their day!

Working from home has become the norm for many of us during the pandemic and it looks like it might just be here to stay for a lot us too! It’s great to have the flexibility that comes with working from home, but it’s also a totally different ballgame and something that we need to adapt to as it certainly comes with its challenges. Whether you’re a work from home pro or are still struggling to get accustomed to this new way of life, here are some top tips and reminders to help keep productivity high on a work from home day without compromising your wellbeing: 1.     Try to get into a routine. It can sometimes be tempting to sleep in on a home office day and just roll out of bed and get straight into work, but it’s far more beneficial to get into a routine and have time to mentally prepare yourself for the day ahead. It’s also nice to have some time to yourself before diving into work. Use the time that you would usually spend commuting in a positive way, you could try yoga, meditation or even just spending extra time treating yourself to a lovely breakfast! Did someone say pancakes?2.     Create your designated workspace. Whether you have an office room or not, you should avoid working from your bed or sofa as these should be your spaces for relaxation. Try to create a working space with a desk/table and a comfortable chair and make it YOURS, add items to make it an enjoyable space to be in, this could be your favourite plant or some artwork but try to keep clutter to a minimum because, after all, a tidy space = a tidy mind!3.     Don’t overwhelm yourself. Making a plan for each day can be really valuable and help to give your day some structure but be realistic about the how much you can get done. Make your to-do lists reasonable and be flexible! If you give yourself too many tasks to complete in one day, the thought of even starting the first task can be so daunting that you’ll be more likely to procrastinate and have to rush through your tasks later on. Figure out what works for you for instance, some people like to work to a schedule and adopt time management practices such as the Pomorodo Technique (work for 25 minute intervals, followed by a 5-10 minute break).4.     Take a proper break! When you’re working from home, it can be strangely easy to just keep working through lunch and not step away from your desk for a proper break and change of scenery, but studies have actually shown that taking time away from your desk can directly increase productivity and creativity! Going for a walk or spending time outside is even better for your well-being, soak up that Vitamin D!5.     Hydration, hydration, hydration. Okay, you’ve heard this 100 times before but it never hurts to be reminded. An easy way to ensure that you’re drinking enough water is to buy a time marked water bottle. Fill it up in the morning, set yourself a challenge and make sure that you finish it before the end of the day. You might just notice that your concentration is better, and it will help to keep headaches at bay, particularly when you’re on screens all day!6.     Limit distractions. Of course, we can’t always control everything but do try to control what you can. If you have a particularly demanding project or are under time constraints, you could try removing distractions; let friends/family know not to disturb you, close the door, put your phone on airplane mode or in another room and switch off that TV!7.     Try a productivity tool/app. Utilising productivity tools can be the extra push that you need; they give you incentives and motivate you and there are so many to choose from! Try an app such as Forest, where you plant a virtual tree that takes, for example, ten minutes to grow, and if you can stay off your phone long enough, the tree will finish growing and be added to your on-screen forest, but if you return to your phone too fast, the tree withers and dies. It’s a light-hearted way to avoid digital distractions and gives you a sense of satisfaction! What tips do you have to stay productive at home?

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?