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BLOG - Tracking Recruitment Trends
24th April 2019

The Past, Present & Future of Regulatory Requirements

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Throughout the past 3 years that I have been focussed on the UK market of Regulatory and Quality, there have been some vast changes that have really hit these industries hard.  I have chosen 3 of the biggest trends below that I think best summarise the huge shift in Regulations, and the massive impact this has had on the industry (from a recruitment perspective).  The changes that I think best highlight the industry shift as a whole are; the new MDR, Brexit, and of course a shift into using Regulatory consultancies instead of employing internal teams.  Let me know whether I have missed anything from the below.

 

The Past – “The Device does not Suffice”

 

To fully understand the biggest trend of the last 3 years, you must first go back to 1991, when Jean-Claude Mas founded P.I.P (Poly Implant Prothese) in France, a company that specialised in the creation of Breast Implants.  For years, despite several warnings, these were implanted into people’s bodies without too much fuss and with little public disturbance.

 

Then in 1996 PIP announced the launch of saline-filled breast implants.  4 years later, in the year 2000, the FDA rejected these implants as they were unsafe, and the company voluntarily discontinued production (due to lack of safety data).

 

To counter this, PIP then started using unapproved industrial-grade silicone in their breast implants, and this was where disaster struck.  By 2009 several reports of high rupture rates had made their way to the media, and the lawsuits flooded in.  By 2010 the company was wrapped up and Doctors were urging people to get their implants replaced ASAP, and by 2013 Mas was imprisoned.

 

So, what was the end result of this saga from a regulatory standpoint? The 2017 Medical Device Regulations came into force.  (NB: These were not just down to the PIP situation, there were several other similar issues with a variety of Medical Device products, PIP just had the highest profile).

 

In the recruitment world this meant that from 2017 – 2018 the majority of Medical Device companies were busy re-registering their products with the relevant regulatory bodies, and were making sure that they had MDR specialists on site all the time.  Regulatory recruitment focused a great deal on people that had studied and worked with the new MDR, instead of people with many years of existing experience.

 

It really did create a huge industry stir for a 12 month period.  It even saw a boost in companies that used specialist ‘regulatory consultancies’ in order to get products re-registered efficiently and without being left with too many onsite hands once this was done.  In total, last year saw a 12% rise in the use of external regulatory agencies, and a big factor of this was the Medical Device spend.  On global job boards phrases like “CE Marking” and “Technical File Creation” became two of the popular searches for regulatory CVs.

 

… and this spiral didn’t stop until June 2018. 

 

The Present – “Should I stay or should I go”

 

Not just the name of a great song by the Clash, but a sentiment shared by millions of Brits up and down the country.  Over two years on from the Referendum, and not a great deal has changed, and we are still operating in an extremely uncertain environment.

 

As a reaction to this,  some companies have been focusing on re-assigning products to their European offices to ensure they continued production.  Others have moved their head offices entirely.  Even the EMA (European Medicines Agency) decided they would relocate from London in favour of Amsterdam.

 

The end result of all of this upheaval is that that a lot of companies have needed regulatory bodies on site to help with Technical / Site Transfers, relocation strategies, and the development of contingency plans for the business as a whole.  Like The Ghostbusters, when everything went wrong, regulatory got the call.

 

As the market changed, businesses have focused a lot more on Dublin recruitment, Mainland European recruitment, or UK based regulatory professionals that can help with these complicated changes that businesses are undergoing.

 

This has also contributed hugely to the rise in consultancies and agencies being used and a number of specialist companies have been set up around the Dublin area to help companies relocate and reassign products without having to retain long-term staff (or pay hefty freelancer fees).

 

As you can imagine, this is an ongoing process, and still a great number of businesses need these kind of people on their books.  No decisions have been made (at the time of writing this) in terms of how Brexit will occur, or even if it will and companies are facing a great deal of turbulence either way, so regulatory is really under the microscope (NB: By the way, it’s worth mentioning that anyone interested in a role like the ones mentioned, should stay behind after class and drop me a comment so that we can connect).

 

So what’s next?

 

The Future – “Change is the law of life, and those who look only to the past or the present, are certain to miss the future”

 

Never has a truer word been spoken, than the quote above, said by the 35th President of the United States, John F. Kennedy.

 

And he’s right.  We can’t only analyse past and present trends, whilst blindly ignoring the future. Aside from the ongoing disruption regarding Brexit, what’s next?

 

To my mind, with the way things have been progressing I think that we will certainly see an even greater rise in consultative representation through agencies and regulatory groups, but I also think that there will be a vast increase in permanent hires once the turbulence settles a little, maybe surrounding the clinical sectors to support their increasing workloads.

 

That being said, it’s not about what I think.  You, the lovely people in my network who have taken the time to read this far, are literally creating the future recruitment trends with your work and your businesses – so a question to the floor….

 

What is the next big recruitment trend within the healthcare industry?

 

Reach out to discuss this topic in more detail with Luke. Contact details below. 

 

Written by Luke Blaney - Regulatory Affairs & Quality Assurance Consultant

luke.blaney@rbwconsulting.com

+44 (0)1293 584 300

 

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