Spotlight on French Medical Device Regulatory Affairs

Associate Partner? Hoel Goasguen , who recruits French medical device regulatory affairs professionals gives an overview of the industry in this edition of our Spotlight series.

What are the main challenges affecting hiring in the market and why?

Regulatory affairs professionals have very specific profiles given how regulated the medical device industry is. Companies manufacturing medical devices would be unable to sell their products without adopting the proper regulatory framework, therefore, these profiles have huge strategic importance for companies. Unfortunately, there is a high demand for experienced regulatory profiles in France, and not enough candidates to fill that demand. Candidates are also likely to move around jobs every three to four years too.

Due to this, we have seen a sharp increase in salaries in the last two years, and more benefits on offer as companies compete for talent. The most typical benefits are smart working, flexible hours, training provision, and career progression options.

How can we overcome those challenges?

In addition to trying to remain competitive with salary and benefits, I always advise my clients that reputation is extremely important in this field as candidates often talk to each other. Word of mouth is the best form of advertising and unfortunately, for companies with a less-than-ideal reputation, this can harm them when it comes to hiring the talent they need.

The biggest problem in terms of reputation is generally the lack of resources over time. Not many companies understand the full importance of the quality and regulatory sector, seeing it as an obligation rather than something that will drive the company forward. In the meantime, it also represents a huge amount of work, and the proper resources need to be allocated, which is not cheap. Without proper investment in these teams, people tend to disengage over time, leaving the company unstructured, which can lead to negativity too.

Most common FAQ from clients

I think the most common question I hear is how companies can hire experts on the new 2017/745 MDR regulation. Since the application of the new European MDR regulation last year, most of the companies have been looking for the same profiles and typically requesting three to five years of experience, with strong knowledge of this regulation.

However, with the regulation being fairly new, not many candidates can truthfully say they are experts on the topic, especially as many trained themselves using official documentation, without receiving proper “official” training. Assessing the knowledge of the candidates is therefore extremely difficult as the regulation sometimes leaves space for personal interpretation.

On the other side, we have newly graduated candidates who have received proper training on this regulation, yet lack any practical experience. A solution is to give candidates a case study or short exercise that asks them to resolve a regulatory situation. It could be an issue that the team faced in the past and was able to resolve for example.?Because a lot of regulatory problems have more than one correct possible answer, it’s also a good way to understand if the candidates are in the same mindset as the rest of the team, or if they are agile, solution-oriented, and able to provide an interesting input on a specific topic.

Most common FAQ from candidates

How to find their first job. Unfortunately, due to the situation stated above, many recently graduated candidates struggle to find their first job in the field. Because of the urgency introduced by the new regulation, and short deadlines to respect, many companies are still reluctant to hire entry-level candidates for this position.

I typically advise such candidates that internships are the best way to acquire a first experience that will be very valuable when looking for that first job. Otherwise, some organisations like AFNOR can provide complementary training on specific topics that can also be valuable. Meanwhile, as recruiters, we can work on behalf of the candidate to convince certain companies to consider their profiles, even if they are not initially open to recruiting entry-level candidates otherwise.

Any predictions for hiring in this market in the coming two to five years

The regulatory market will definitely remain in high demand for the next five years. While the regulation is becoming more and more complex, companies understand the crucial importance of such profiles. There are not enough candidates right now to fulfil the demand. However, that demand might stabilize around May 2024, when the deadline for MDR compliance is requested for companies already complying with the previous MDD regulation (if the deadline is not extended).