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.
- 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?