RA People featured in Biotech NEWS & Life Sciences
RA People was featured in the November edition of Dutch magazine Biotech NEWS & Life Sciences. Our director Carl Lens gave an in-depth interview about ways to power up your regulatory team. Click the link below to view the article in PDF. This publication is written in Dutch.
Ready or Not, Changes Are Coming to Legacy Device Requirements in the EU
One of the most challenging hurdles of the European Medical Device Regulation is time. Manufacturers still have a lot to do over the next two years to ensure compliance. Fully review all their currently EU marketed devices, but also take actions on those results. Is your company ready?
RA People at RAMD 2018 in London
We are very happy to be part of the 2nd World Congress on Regulatory Affairs for Medical Devices (RAMD2018), which will take place 2 – 3 July 2018, in London, United Kingdom.
Powering up your regulatory team
It is difficult for medical technology companies to find Regulatory Affairs Specialists: people who can succeed at the interface of regulations and technology.
RA People’s services combine finding, recruiting, and training Regulatory Affairs Specialists for you. We find people with the right basic profile to become an RA Specialist and train them using a unique concept that involves working and learning from day one. You won’t need to worry about recruitment or training, and for a period of one year will have the opportunity to get to know and integrate our RA Specialist-in-training in your own work environment. And if it’s not a good match, the work will stop.
RA People was founded by Carl Lens and Willemijn Berg. Carl has many years of experience in Executive Search and owns Lens, Executive Search. Willemijn is a seasoned expert and manager in building physical and digital corporate Academies and owns Berg Development.
“Powering up the Regulatory Team will be a necessity in the coming years.”
– Global Head of Regulations from a major device manufacturer
Why RA People’s services are vital for the MedTech sector
The new Medical Device Regulation (MDR) brings a period of major change, uncertainty and new opportunities in the market of medical technology and diagnostics. The expectation is that there will be significant shortages of trained specialists with the right knowledge and experience in this area.
Maetrics states in their 2017 report: “Non-compliant organisations will not be able to participate in markets until compliance is achieved. In turn, this creates opportunities in the market for the MDR compliance pioneers, who will be able to serve the resulting market segments while non-compliance continues to exclude their competitors” (1). So, the cost of not being prepared for the MDR will be substantial for those who depend on compliance with EU rules. At the same time, “the cost of compliance will most likely be significant.” According to Deloitte, it is “critical that businesses take action now (to ensure stakeholder buy-in), prepare their organisations and start implementing changes” (2). There is no cheap way out. And if you want to stay in business, you have no other option than to invest and be ready.
The expectation is that there will be significant shortages of trained specialists with the right knowledge and experience. It is already a challenge for MedTech companies to find and hire Regulatory Affairs Specialists: people who can succeed at the interface of regulations and technology. Maetrics is no less pessimistic: “Although a transition schedule has been put in place for compliance, this masks the fact that there is a rapidly emerging capacity shortage within notified bodies (certification) but also in terms of expert compliance staff and consultants (preparation). Therefore manufacturers that do not embark urgently and early on in their compliance preparation and certification are likely to find themselves unable to achieve compliance across their product portfolios by the statutory deadline.”
This is where RA People’s solution comes in: despite shortages of trained staff, it is still possible to achieve the necessary compliance staff capacity while maintaining quality levels. Our Specialist-in-Training formula provides just that: the answer to an unbalanced market where ordinary job searches no longer answer your needs.
1. Maetrics, The market opportunity value of the EU MDR, 2017.
2. Deloitte, Preparing for the future: The new European Union medical devices regulation, 2016.
“The demand for Regulatory Affairs professionals will be greater than you will be able to supply.”
– Managing director of a major industry consultancy
This is the main reason why we started RA People, filling the need from the market by training people on the job. We combine search and selection, a state-of-the-art learning platform, training-on-the-job and relevant work experience to help answer this growing demand.”
Carl Lens has worked in recruitment in the international healthcare industry since the early nineties. In the past decade, he has done so with a team of 10 people from Amsterdam who are part of an international network of recruitment agencies. Lens has many long-standing clients, from big corporates in active implants to small start-ups in diagnostics and e-health. And every discipline is covered, including clinical, R&D, regulatory, value-based healthcare, medical, marketing and sales. Alongside his executive search activities, he now devotes the majority of his time to RA People.
“Your initiative comes at exactly the right time, although not everyone in the industry feels the real urgency.”
– Senior Consultant, Regulatory Affairs and Quality
RA People Academy
RA People recruits people who match the profile of a Regulatory Affairs Specialist. The RA People Academy incorporates different learning and teaching methods and begins when the participant starts working as an RA Specialist at one of our customers. The programme takes around a year to complete, and alternates between instructor-led training, e-learning, self-study, assignments, peer learning, optional modules and coaching. This continuous learning process is supported by an online learning environment.
RA People at the MedTech Forum in Brussels
It goes without saying that RA People was present at the last MedTech Forum in Brussels in January 2018 to discuss the initiative of RA People with the attendees. All of the professionals who attended agreed that the lack of Regulatory Affairs Specialists in the market poses a real threat to the MedTech industry’s strength and competitive edge in Europe. This applies to the industry, the consultancies and the notified bodies. Moreover, there are no simple solutions, because there is a shortage of Masters programmes on this specialist field. Most of those we spoke confirmed the uniqueness of RA People’s services.
“The introduction of the MDR presents a real challenge for the world of medical devices.”
– Global Head of Regulations from a major device manufacturer