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The introduction of the EU Medical Device Regulation (MDR) and the associated IVDR has paved the way for higher safety and quality standards in medical technology - despite what was initially perceived as an obstacle. Exciting developments are emerging in the area of MDR Regulatory Affairs in particular, but there are also still relevant challenges, especially when it comes to filling key positions in Regulatory Affairs.
At the beginning of 2017, the EU Parliament adopted the comprehensive regulation that is to replace the previous medical device directives. The introduction originally planned for 2020 was postponed by a year due to the coronavirus pandemic. This additional preparation time proved to be a double-edged sword for many companies: on the one hand, internal processes could be optimized, but on the other hand, the shortage of specialists in the area of regulatory affairs became particularly apparent.
Lack of training programs: There is still no standardized course of study for regulatory affairs in Germany. It is often a mix of a life science degree and additional further training that makes up the qualification.
Industry experience and specialization: Decades of experience in various segments of medical technology are often necessary to map the complex requirements of the MDR and IVDR.
Uncertainty among small companies: Many small and medium-sized companies find it difficult to formulate job advertisements that are a perfect fit and to ask the right questions in interviews, which leads to further hurdles in the recruitment process.
Professionalization and further training
Further training in the field of MDR regulatory affairs has become much more professional in recent years. Numerous specialized certificate programs and workshops have been created to raise the professional level of applicants. These programs not only provide regulatory know-how, but also practical insights into the implementation of the complex regulations.
Digitization and automation
The increasing digitalization of the process landscape in medical technology has not stopped at regulatory affairs. With the help of modern software solutions, administrative tasks, reporting and compliance monitoring can be automated. This development relieves the burden on specialists and allows more capacity to be invested in strategically important tasks.
Due to the continuing tight candidate market, many companies are increasingly turning to alternative recruitment strategies:
Talent pools and networking
Many companies develop their own talent pools and use industry-specific networks to identify suitable candidates at an early stage.
Internal training
Companies are increasingly investing in the training of existing employees in order to fill vacancies internally.
Cooperation with specialized personnel consulting companies
Experts like BESTMINDS have been supporting companies in their search for highly qualified regulatory affairs managers and specialists for over 15 years - with a deep understanding of the industry and a broad network.
Compliance with the MDR guidelines is crucial for market access and patient safety. While some companies still find the complex regulations a burden, there is a growing awareness that well-positioned regulatory affairs departments make all the difference.
Advantages of a strong MDR Regulatory Affairs department:
Risk minimization: A competent team can identify and minimize regulatory risks at an early stage.
Competitive advantages: Companies that implement the requirements of the MDR precisely often enjoy a greater advantage in terms of trust on the international market.
Increased efficiency: The use of digital tools speeds up processes and reduces documentation gaps, which has a positive impact on overall performance.
The trend is clearly moving towards further specialization and the integration of interdisciplinary skills. Future MDR regulatory affairs experts will not only require regulatory expertise, but will also need to be trained in areas such as data analysis, artificial intelligence and digital health technologies.
Key factors for future success:
Lifelong learning and training: In the face of ever-changing regulatory requirements, continuous training is becoming the norm.
Interdisciplinary cooperation: A close exchange between Regulatory Affairs, R&D, Production and IT is essential in order to meet regulatory challenges holistically.
Innovative recruitment strategies: In addition to the traditional application process, companies should increasingly rely on digital platforms and industry-specific networks to counter the shortage of skilled workers.
While MDR and IVDR present the medical technology industry with new and complex challenges, they also offer the opportunity to improve quality and patient safety. Filling regulatory affairs positions remains a challenging task - but through targeted training, the use of modern digital tools and innovative recruitment approaches, companies can pave the way to a regulatory-safe future.
You too can rely on a long-term partner who will support you in all matters relating to MDR regulatory affairs - whether through tailored advice or the placement of highly qualified specialists and managers.
Contact us for a non-binding initial consultation and get started today on a successful future under the new regulatory framework.
