3 ways to spot post market surveillance talent | Elemed

What is post market surveillance for medical devices?

Your new, cutting-edge medical device has been designed and tested, and is ready to get out into the world to start making a difference to patients around the world. You have a stellar go-to-market strategy in place and can’t wait to show your customers just what your new medical device can do. But how do you make sure your medical device stays safe and effective once it’s on the market? Post market surveillance is the answer. This system – which is a regulatory requirement for medical devices in Europe and the US – enables continuous feedback about your new product in the market, with a view to maintaining a high standard of product quality.

It’s important to get your post market surveillance system working well. The benefits include being able to improve your medical device and deliver better results for your customers, and catching any problems before they happen at scale. Implementing a post market surveillance plan isn’t as simple as it sounds though. As a regulatory requirement, post market surveillance comes with a whole host of obligations and responsibilities that can make it feel overwhelming. 

Hiring a talented professional who specialises in post market surveillance for medical devices is the best way to ensure that your system is enabled effectively, efficiently and with full compliance. Read on for the 3 sure signs that your post market surveillance candidate is great at what they do!

Core competencies 💪

There are certain core competencies that every excellent post market surveillance professional should have. Your   checklist should include direct experience leading post market/complaint handling and vigilance activities. If they have a  Bachelor’s degree in engineering or science degree that’s a bonus! Perfect candidates will have 3-5 years of related experience in the medical device industry too. You’ll also need to look for someone who has demonstrable experience in regulatory audits, incident reporting and working to medical device regulations including MDR and ISO13485.

  1. Standout skills 🧠

It’s not all about the person’s hands-on post market surveillance experience. A great PMS professional will have soft skills that really shine. You need someone who can confidently make decisions and effectively communicate detailed, technical information and strategic decisions to colleagues at every level across the business. Post market surveillance is all about processes, so your dream candidate should excel in implementing, optimising and driving processes across organisations. They will have a keen eye for trend analysis, with a commitment to accountability and a strong customer focus. You should also look out for candidates who show the ability to think quickly, react confidently and work efficiently in the face of a problem or complaint. 

  1. Unrivalled passion – even for regulations ❤️

Look for someone who doesn’t just know their MDR from their IVDR, but who lives and breathes them. A great post market surveillance candidate will be passionate about every last detail of their work, down to the smallest regulatory requirement. They will thrive in the face of compliance and love the challenge of watching a great medical device work its wonders for customers whilst looking for ways to improve and optimise its performance.

What happens when you find your perfect post market surveillance candidate? 🤝

So you’ve found your ideal post market surveillance professional – what now? The worst possible outcome is that they decline your offer or take a job elsewhere. Excellent candidates are worth fighting for, so be prepared to pay close attention to their expectations and motivations. Do they want a few days working from home each week? Are they financially motivated and expect an annual bonus on top of base pay? Maybe taking care of their mental health is a top priority for them and they’re looking for a role with genuine support. Whatever it is that your candidate is looking for in their dream job, if they are your dream candidate it is worth being flexible and meeting their expectations where you can. Don’t just take our word for it – we have data in our Talent Insights Report that shows how work-life balance is extremely important to candidates – 91% of participants expect their company to offer flexible working hours and 73% expect the possibility of working from home.

Where to start?

If you’re ready to find your perfect post market surveillance professional but aren’t sure where to start, we can help! We have a network of over 15,000 medical device and IVD professionals, and have lots of experience filling exclusive roles. Our network includes some of the best post market surveillance medical device talent in Europe, with many of our professionals waiting on their perfect next career step. These aren’t people sending out their CVs every day in the hope that they find the right position – they are relying on our help to bring the dream position to them. If you want to find out more about how we can help connect you to your perfect post market surveillance candidate, get in touch today!

IVDR regulation | How to hire the right people | Elemed

Finding the right talent to navigate the IVDR regulation

The medical device industry is on countdown. The 26th May 2022 IVDR deadline is fast approaching, and with it comes an updated set of requirements and regulations for new in vitro diagnostic devices in the EU market. Companies with existing IVDs on the market, which have already been certified by a Notified Body, may have until 25th May 2024 under some conditions.

Medical device and diagnostics companies across Europe have been preparing for the new regulations for the last few years. The IVDR came into force on 25th May 2017, and businesses have been planning how to approach the transition and ensure that their teams are ready to meet key deadlines as the timeline progresses. But what is the right way to approach sourcing and hiring IVDR talent? You need people on your team who are confident in understanding the IVDR classifications, who can offer guidance across your company and ensure compliance with the new regulations.

If finding the perfect IVDR hires hasn’t been on your agenda yet, now is the time to make it a priority. We can guarantee that your in vitro diagnostics competitors already have the wheels in motion to find EU IVDR experts for their team, if they haven’t hired them already, that is. Robyn Meurant – Executive Director of Regulatory Services, IVDs and Medical Devices at NSF Health Sciences Limited – advises:

“With less than a year to go, many companies are now realising the size of the task at hand to meet the IVDR – be it manufacturers, notified bodies, economic operators, and even labs that don’t qualify for a health institution exemption. If you are one of these, now is the time to bring in new staff; any later, and you will be caught wanting.”

Here are three strategies to sourcing and hiring the best people to help your business navigate the IVDR regulation and guide your colleagues through the new requirements to compliance and success. 

1. Hire junior staff and train them up

Yes, the IVDR deadline is fast approaching. But that doesn’t mean that there isn’t time to bring in junior members of staff and get them fully trained up on the nuances of IVDR, creating your own team of internal experts. There are external training providers poised and ready to transform your junior hires into IVDR regulation masters, from classification all the way through to post-market surveillance. The graduate talent pool is the perfect place to find junior people who are still receptive to learning and development, with a fervent passion to prove themselves and impress. This is the ideal combination for a junior hire and will ensure that you’re not left behind as the IVDR timeline progresses and the new regulation edges closer. Taking this route will be your cheapest option for recruitment but it will also take the longest to get your business IVDR-ready. 

2. Hire experienced regulatory affairs people from medical devices

There are risks associated with hiring junior team members and training them in IVDR regulation. Risks that you can avoid by hiring experienced regulatory affairs professionals from the medical devices industry who have already worked through the implementation of the Medical Device Regulation. They might not have the IVD experience you’re looking for, but their commitment to the industry and their medical device expertise is undeniable. Experienced RA professionals will be used to understanding and implementing changing legislation, classifications and requirements, meaning they will be able to pick up the IVDR regulation with speed and ease. You can be sure that they will have a lot of cross-transferrable skills and will approach IVDR with professionalism and expertise. 

3. Hire IVD people from other disciplines

If you’d prefer to inject pure IVD experience into your team for a no-hassle, hit-the-ground-running solution, then consider hiring IVD professionals from other disciplines within your own company. Look for talent in R&D or quality and train them on the requirements – these people will bring years of specific technical IVD experience that will make your company’s adoption of IVDR and your transition to the new regulation much smoother. 

Create an employment package candidates can’t say no to

We’re not just talking about IVDR salaries here! What happens if you find your perfect IVDR candidate but they are receiving offers from other companies? After all, these professionals are about to be very in demand as medical device companies prepare for the EU IVDR updates. Your company and the employment package you offer has to stand out. In our Talent Insights Report, we found that work-life balance is extremely important to candidates – 91% of participants expect their company to offer flexible working hours and 73% expect the possibility of working from home. Other key differentiators that can swing a candidate’s decision in your favour include the role itself and base salary. The only real way to make sure you win your candidate of choice over is to know them inside-out, as an individual with ambitions and a life outside of work, and tailor your offer to them. Recruitment consultants can add value and support here, by bridging the gap between you and your candidate, sharing insights and nurturing the relationship on your behalf. 

Take the next step in building your IVDR regulation ready team

Candidate experience and skills are important when recruiting, but so are soft skills and culture fit. With the pressure of the looming IVDR deadline in 2022, you might feel tempted to compromise on the perfect candidate by hiring from the candidates actively applying to jobs. According to our report, by taking this approach you’re only reaching 15.47% of the market and risk hiring someone who is more likely to leave the business quickly or be considering multiple other offers. What if you could access a pool of untapped, specialised talent that isn’t sending their CV to every role out there? The only way you’ll ensure a smooth, successful transition to meet the IVDR requirements is to find a candidate that is a great fit in every respect. Enter Elemed! We have a network of over 15,000 medical device and IVD professionals and a 100% fill rate on exclusive roles. Follow Robyn Muerant’s stellar advice:

“With the IVDR fast approaching it’s imperative for success to have the right people in the right job right now.”

Get in touch to discuss hiring the right people for IDVR today.