Industry news -

MDR / IVDR: Regulatory Affairs positions, whether RA Specialists or RA Manager and Director are difficult to fill

Due to corona, the Medical Device Regulation (MDR) and the IVDR were postponed to May 2021. With this, the regulatory requirements for bringing medical devices to the market are increasing throughout Europe. The majority of companies see this as an obstacle for the entire industry.

Graphic: Bundesverband Medizintechnologie e.V., Reinhardtstraße 29b, D-10117 Berlin, Tel.: +49 (0)30 246 255 – 0 V.i.S.d.P.: Manfred Beeres, Leiter Kommunikation/Presse,,

At the beginning of 2017, the EU Parliament passed the very comprehensive EU Medical Device Regulation (MDR). This is intended to replace the previous medical device directives. Likewise, the 477-page new regulation IVDR - In Vitro Diagnostic Device Regulation, which replaces the previous IVD directive (98/79/EC). The regulations should come into force on time in 2020. However, these were postponed by one year due to the corona pandemic. This gave companies enough time to prepare for the new regulations. Despite this, most of them are uncertain about the future. Why is that?

Lack of expertise

In Germany there is no course of study for the Regulatory Affairs Specialist or Manager. A mix of a life science course of studies and adequate further education defines this group of professionals. Therefore it is often difficult to see through who is qualified for the position in one's own company or not. Years of industry experience in several fields are required to find the right candidate with certainty. Many small or medium-sized companies find it difficult to publish the right job advertisements and ask the right questions in job interviews. This uncertainty is also reflected in BVMed's Autumn 2020 Survey. There, 81% of all MedTech companies state that the Medical Devices Regulation is an obstacle to the development of the entire industry.

Missing applicants

For an extensive change of regulatory requirements, highly qualified specialists are required in one' s own company. To manage the increased workload, each company would have to hire one or more additional Regulatory Affairs staff (m/f/d). Due to the strong demand, however, the applicant market is largely exhausted. Direct headhunting is often the only solution for companies.

Our expertise will help you

Many years of work experience in the field, professional excellence and an outstanding network are required to find and fill the right Regulatory Affairs Specialist or Manager for your company. You will find such expertise at the personnel consultants of BESTMINDS. Our recruitment consultants have been recruiting highly qualified specialists and managers in the medical technology, diagnostics and pharmaceutical industries with great dedication and commitment for over 10 years. Fair, loyal and discreet, they meet your challenges and wishes. Please contact us for a non-binding initial consultation in order to fill your new employee (m/f/d) according to your requirements.

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