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Why a person responsible for regulatory compliance is crucial in 2021
Why a PRRC is crucial for regulatory compliance
The rise of the PRRC
Now is the era of the PRRC. Since the start of the pandemic, regulatory compliance and affairs has had a re-brand, moving from ‘just another department’ to a key strategic partner for many businesses. This raised profile has highlighted the fact that regulatory compliance is not just about knowing the rules and regulations inside out – it’s also about exceptional negotiation skills, proactive and reactive creativity, multidisciplinary communication skills and being able to navigate the grey where other teams can’t. It is regulatory affairs professionals who sit at the forefront of bringing products to market quickly – a responsibility which has been more important than ever in the face of Coronavirus and the need for vaccines and virus detection medical devices.
It’s not just the pandemic that has raised the global profile of regulatory affairs compliance professionals. The European Commission’s guidance in response to the new MDR 2017/745 and IVDR 2017/746, says that manufacturers and authorised representatives must have at least one member of staff who is a designated person responsible for regulatory compliance (PRRC) to the MDR and/or IVDR. So, if you’re a medical device manufacturer or authorised representative then it’s imperative that you have a PRRC on your team.
What will a PRRC do?
Under MDR 2017/745
According to Article 15(3) of the EU MDR 2017/745, the PRRC of a medical manufacturer is responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Under IVDR 2017/746
For PRRCs working according to Article 15(3) of the EU IVDR 2017/746, their responsibilities are:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(9);
(d) the reporting obligations referred to in Articles 82 to 86 are fulfilled.
(e) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.
What makes a great PRRC?
Your person responsible for regulatory compliance needs to be a fantastic communicator, as they’ll need to communicate across different layers of your business, with customers and with external certifying bodies. They’ll need to have a demonstrable background of technical, protocol and report driven work, with fantastic attention to spoken and written detail. A great PRRC will also be able to show their experience in working with a flexible, proactive and hands-on approach to their work.
According to MDR 2017/745, the person responsible for regulatory compliance should have:
a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
or
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
For IVDR 2017/746, the PRRC’s experience must pertain to in vitro medical devices.
How to hire a great PRRC
When it comes to adding a PRRC to your team, you have a few options to consider. The first is to look internally for someone who has the required skills and experience. If there is no one suitable, you can either:
– Hire a new employee that will fulfil this role
– Hire a consultant for a certain period of time until one of your internal employees gets trained
PRRCs are in high demand right now and competition for the best ones is high! We’re on hand with our highly coveted network of over 20,000 MedTech professionals to not only help you find the best person for the job, but to also make sure they join your company and not a very attractive competitor.
5 signs of a great regulatory affairs recruitment agency
5 signs of a great regulatory affairs recruitment agency
Finding regulatory affairs talent – especially at a senior or leadership level – can be a challenge. Whether it’s for a newly created position or to fill a recent resignation, finding and then securing the perfect candidate can be difficult. There are so many elements that come into play: finding someone with the required (or better!) experience, attracting exceptional candidates that maybe aren’t yet actively looking for a job, ensuring that the person you hire has the right attitude and personality to fit in with your company, creating the perfect job offer that your chosen candidate can’t say no to.
Now factor in another layer of complexity – finding regulatory affairs talent in the medical devices and IVDs industry. Finding the ideal candidate in this niche industry can sometimes feel like looking for a needle in a haystack, especially when you are trying to meet all the criteria listed above. It’s possible that the right candidate for you – the one with the perfect experience, attitude and expectations – is only just starting to think about a new job, in which case they won’t be actively searching for roles or looking at medical device regulatory job listings. How can you possibly let them know about your fantastic job offer in regulatory affairs if they aren’t looking on your website? Capturing the attention of that person, whilst looking through the haystack at the same time…. It isn’t easy!
At this point, where the fear creeps in that you might never find the perfect person to join your company and help push it forward to greater success, it’s time to enlist the help of a recruitment agency. Not any recruitment agency either – you need a great regulatory affairs recruitment agency that specialises in medical devices and regulatory affairs. Look out for our 5 markers of a great regulatory affairs recruitment agency to know you’re working with the right one!
1. Specialists in medical devices and regulatory affairs
Most generalist agencies will recruit across multiple industries and lots of different role types. They might have a good approach to recruitment and attractive rates, but do they have the network, proven track record and trust of the candidates you are trying to reach? Great agencies will be medical devices and regulatory affairs experts, with a laser-beam focus on what it means to be a successful medical devices company in the current market. They will talk confidently to you about the impact of changing regulations such as MDR and IVDR, and the implications such changes might have on your business’ hiring needs later on down the line. How can you know what you’re looking for is realistic, that you’re paying the right salary, and what it is that makes you stand out against all the other roles in regulatory affairs? They will share their own market insights and data with you, to make sure you have all the relevant information needed to make the right hiring decisions for your business.
2. Connected to a wide network that you would otherwise not have access to
A fantastic regulatory affairs recruitment agency will have a warm database of candidates who engage with them on social media, on their website, by email, and as part of company events and programs. They will have relationships that mean that when they call, your perfect candidate will answer. This network of regulatory affairs professionals – all with the kind of medical devices experience you are looking for – might not be actively looking for new jobs. But with the visibility that a great regulatory affairs recruitment agency can provide in terms of promoting new jobs and the insights they have over signals that suggest someone might be about to look for a new job – this means that suddenly, with the right agency, your open positions are being presented to exceptional candidates who would otherwise not have seen them.
3. Embedded in the medical devices community
It takes a really great regulatory affairs agency to not just work in the medical devices industry, but to be valued as an important and contributing part of it. This makes the conversations between recruitment consultants and candidates even smoother and more effective, as they already know and respect the business and its team. Look for agencies who are thought leaders – those that are considered integral to the industry by its members, with team members who lead the way in terms of medical device conversations and resources. These agencies are more than just suppliers, they are trusted strategic advisors.
4. Proven success rate with companies like yours
A great regulatory affairs recruitment agency will have a fantastic history of success – look for how many years they’ve been operating for (especially in medical devices and regulatory affairs) and great client testimonials that speak to the hiring challenges you are facing. It’s important to not just focus on the client side; look for candidate testimonials and don’t forget that your chosen recruitment partner will be an extension of your company brand. They will represent you in the market. Testimonials are excellent proof that the agency you’re considering puts time and energy into creating perfect client/candidate matches. One challenge you may be facing when recruiting senior regulatory affairs professionals for medical devices is simply having the time to find the best candidate. Great agencies with well-versed processes and proven success rates run efficiently and effectively, meaning that you can put your trust in them to do a brilliant job.
5. Supportive throughout your entire working relationship, not just when you have a position to fill
A really great regulatory affairs recruitment agency will be there for more than just finding and placing your candidate. They will be there to support you at the very start of the process, when you’re facing an unexpected resignation or are trying to benchmark salaries. They will use their specialist knowledge to help you understand the talent landscape, employment trends, and give you competitive market insights that you won’t be able to find publicly.
Use this list as your checklist when assessing regulatory affairs recruitment agencies for your medical devices hiring needs. Do research on social media – especially on LinkedIn – and visit their websites to get a better understanding of their calibres. Speak to industry peers for verbal recommendations and, if you’re curious to know how the team here at Elemed can help, get in touch with us now.
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 as the IVDR deadline approaches
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 to pick IVDR up with ease
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 your IVDR 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.
