Clinical

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?

David James, our CEO recently caught up with our Medical Device Recruitment Team at Adaptive Life Science, Rebecca Stevens and Hollie Barry, where we discussed all things in relation to CVs in the MedTech industry!The structure is an easy fix. It is the content which truly differentiates you and gives you a competitive advantage to stand out to employers. Our goal is to demystify the Life Science CV to give it the substance that will make an employer stop and want to speak with you.From the common, and often easily avoidable, mistakes that we see in CVs throughout the industry, how to make your CV stand out, and reflect your suitability for a dream role!What common mistakes do you see on CVs in the Life Science industry?Rebecca: The most pertinent aspect of your CV is clarity and often there is not enough information on positions and industry experience. No two Medical Device companies are the same, not by structure, role or responsibility, so don’t assume that an employer will have a holistic understanding of what you do without proper explanation. We have spoken to Specialists who are leading teams of 5+, and Senior Managers with 10+ years who don’t have any management responsibility. The job title is not enough to go by, so make sure you are including your responsibilities and why you were hired for the role – what have you contributed to the department?The most common pitfall we see with medical device CVs is the missing buzzwords that employers will be looking for, to ensure that you know your standards and relevant regulations. Don’t just write about registrations – elaborate on the geographical markets, classes, therapeutic area, active or non-active products, software, IVDs etc... It is great if you are the business process owner for risk management, but make sure you include that you are working in accordance to ISO 14971. These small steps will quickly grab employer attention and lead to arranging an interview.Hollie: Sometimes CVs are just not specific enough – if 90% of your works focus is UDI/labelling, then write this. Don’t mislead an employer and be honest about your limitations, but instead emphasize the areas where you can deliver immediate value to them. If you’re applying for a role, always read the job description and if there are any applicable skills that you bring that aren’t already listed on your CV… add them! Some fool proof things to include but are not limited to: training accreditations (stay up to date), degree and particular relevant focus topics/thesis work, specialist focuses (CAPA/PMS/QMS Documentation etc..) International Standards, markets, MDD/MDR involvement and classes of devices.How do you make yourself stand out as a junior candidate with limited experience?Rebecca: Don’t devalue your experience and trainings received. Include everything, even if only a small part of your role, e.g. sometimes candidates only talk about their experience with non-active devices but on further investigation have worked on one active device and therefore have some knowledge on the electrical standard EN 60601 – it opens up the job market so much further.Hollie: In this case, it’s always a good idea to add any relevant internships you’ve undertaken – include the skills gained from these and any interesting responsibilities you had.How can you make your CV stand out to a recruiter on LinkedIn?Rebecca: Again, always ensuring that you have the relevant buzzwords or skills listed on your profile and make use of the specific skills section. Ensure that the industry is correct (Medical Devices or Biotechnology or Pharma etc...).Hollie: Think of your LinkedIn profile as an online CV, adding a clear and concise description of your responsibilities and focus points is so beneficial and just making sure that you update your skills regularly to reflect your experience. The more detail you share, the more chance you have of receiving actually relevant job enquiries. As an example, I recently spoke to a candidate with the title ‘Quality Manager’ for an ophthalmic medical device company and I had to decipher what his responsibilities were based off the title as there was no further information for me to use. Turns out – he was pretty hands on in registrations and quality was only 20% of his daily focus! If you can share more, it helps us get it right first time.How do you make your CV stand out for a management position?Rebecca: This is easy if you have already been managing and have direct reports or had reports in the past, although we do speak with professionals who are managing teams with full CVs not mentioning their team or number of direct reports. If not and you’re aiming for your first leading position, add any mentoring experience, project leading, supporting interns. Some companies will be open to this and provide the opportunity to develop these skills, but you need to make it easy for them to say yes by highlighting anything relevant.Hollie: I agree, I often speak with candidates who mention that they’ve been training/mentoring others in the team or providing their specialist skills to help the team in a certain area or even managing projects, yet it’s just not listed on their CV. It’s always worth adding any experience you’ve had in these areas especially if you’re aiming for that management/team lead role!What should I include on my CV?Rebecca: Training and accreditations, your degree and any relevant focus topics/thesis work/International Standards, geographic markets, MDR/IVDR involvement, Quality – are you specialising in one phase of the life cycle? Did you set up QMS from scratch or just maintenance? Employers will only have a few moments to review the CV, so this needs to be clear.Hollie: All of the above, and also confirming what classes of device that you work with? What kinds of device - active or non-active, implantable? Make it clear. Are there any projects you’ve worked on that you’re particularly proud of? Focus on the hard skills and less on the soft skills as these will be observed in the interview.It’s a good idea to always keep your CV up to date, whether you are actively looking for a new opportunity or just keeping an eye on the market.We hope that our advice has been helpful to you in some way but we’re also here to assist if you would appreciate some more specific feedback on your newly updated CV. There is no cost to our service, and we will share our honest advice to help put you in the best position for securing that interview! Rebecca Stevens - Global Life Science Recruitment Managerrebecca.stevens@adaptivelifescience.comHollie Barry - Life Science Head-hunter and Candidate Consultanthollie.barry@adaptivelifescience.com 

The global medical devices (MD) market will see a steady growth over the coming years with the sales revenue and international trade value expected to exceed $550 billion and $300 billion respectively by 2020 driven by aging population, increasing healthcare expenditure and technology advancement.But what is it like to work in such an industry, one heavy in regulation but still able to move at a lightening pace. Where companies are bought on the strength of an idea, but only have a small window before competitors strike. A truly global industry searching for the tools to allow us to prolong life…A medical device is any device intended to be used for medical purposes. What differentiates a medical device from an everyday device is its intended use. Medical devices benefit us by helping health care providers diagnose and treat us or by helping us overcome sickness or disease, improving our quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country.Interesting, Challenging WorkMany will tell you the work is interesting and fast paced. This in essence is what most peopelk search for, a career where they will be challenged to think of what has not been thought before and where your very ideas can shape the way we look to prolong life or treat illness.Depending on its Intended Purpose, a medical device may be classified as Class I (including Is & Im), Class IIa, IIb and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required.From a simple syringe to the most complex artificial heart, a career in the medical device industry can give you exposure to devices we simply cannot do without up to the latest nanotechnology being utilized to save livesAmazing Company CultureMany medical devices will begin life as the idea of 1 or 2 people. Maybe it is an adaptation of an original device, a new software idea that can improve performance of existing treatment methods or a radical new idea never been seen before. Because of this there is a wide range of types of company you can work for:The up and coming Start-Up:Fast paced, crazy times…. Lets just get it done mentality needed. Often a melting pot of brilliant minds with brilliant ideas this can be an environment where you are pushed to go above and beyond but the rewards are massive.The medium sized well invested business:The idea was a winner and initial trials have gone well leading to investment. Medical Device companies can attract huge figures of investment from experienced entrepreneurs to the largest private equity firms. At these sized companies you may still only have the 1 device to be involved with but the security is greater now you have a well-funded device that is bringing in sales revenue.The global beast:These environments can be just as exciting as the start up. There could be 100’s of devices being manufactured and sold or just that 1 that every person in the world needs access to. Either way the pressure to ensure regulatory compliance and maintain the share price means work will always be fast paced and exciting, just this time on a global scale!Areas to exploreBiostatisticsClinical Data ManagementClinical DevelopmentClinical OperationsCommerical SalesDiscovery / R&DEngineeringMedical AffairsMedical InformationProductionPVG & Drug SafetyQuality AssuranceQuality ControlRegulatory AffairsTechnical OperationsComputer System ValidationFor more information on any of the areas above please contact our team at Adaptive Life Science