When launching a new medical device on the market, you cannot get around it: regulatory affairs are an integral part of medical technology. In particular, since the approval process of a medical device is the heart of the whole matter. By now, there is also a proper professional title for this: the Regulatory Affairs Manager. For nowadays and especially under the new MDR, it becomes more and more fundamental to know all the specifics of a medical device approval and to know exactly how this complex process works.
Regulatory Affairs - only another melodious term?
But, from the beginning: the term Regulatory Affairs is widely used in the pharmaceutical/medical technology industry and therefore is used both in connection with pharmaceuticals and medical devices. It is about the process of approval of new medical devices or pharmaceuticals and the rules, that must be followed during the process of approval. Thus, the job description of a Regulatory Affairs Manager (short: RA-Manager) can be found mainly in the field of medical technology and in the drug industry, at times also in conjunction with quality management. This article is intended to give a closer look at the profile of the profession of an RA-Manager in the field of medical technology in Germany/German-speaking culture.
Responsibilities of a Regulatory Affairs Manager
The precise area of responsibility of an RA-Manager can vary depending on the position or the company, but often the following elements are included:
- Coordination of projects to implement the MDR 2017/745 or the IVDR 2017/746 and to support the relevant department in fulfilling regulatory requirements
- Accompanying development projects, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentations
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies
- Examining the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
- Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of medical devices
- Realising staff training on the topic of regulatory affairs
- Staying informed about any changes in legislation etc.
In order to be able to fulfil all these responsibilities one aspect is fundamentally important: profound knowledge of the relevant approval rules, i.e. MDR, IVDR, MPG, relevant laws and guidelines, such as MEDDEV, applicable standards, etc.
Training? Studies? How to acquire decent qualification
First of all: in Germany, there is no classic degree course with the exact title Regulatory Affairs. However, there is a great offer of (mostly part-time) further training measures or postgraduate programmes. For the sake of completeness, it should be mentioned that there is the Deutsche Gesellschaft für Regulatory Affairs (DGRA, meaning: German Society for Regulatory Affairs), which is primarily occupied with the approval of pharmaceuticals, and this cannot necessarily be compared to the approval of medical devices.
Thus, the Regulatory Affairs Manager has a job profile that is composed of various disciplines and elements. However, scientific and technical degree courses are often a requirement in job postings, sometimes along with a suitable further training in the field of regulatory affairs. Depending on the company and the job vacancy career jumpers are welcome as well.
In addition to university education, the following so-called soft skills are particularly helpful for a position as Regulatory Affairs Manager:
- Sense of responsibility
- High carefulness and accuracy in the way of working
- Taking actions purposefully and structured
- Communicative ability
A perfect command of both, the German and English language, spoken and written, has become a standard requirement, other languages are always favourable. Several years of professional experience at a medical device manufacturer are also an additional advantage in the field of regulatory affairs.
The required qualifications of an RA-Manager may vary from company to company and may also be more specific sometimes, but eventually the requirements can be brought down to a good common denominator.
Last but not least
Often job postings also state, that tasks from the field of quality management have to be taken over. In some companies, especially with small and medium-sized companies, the function of an RA-Manager overlaps with areas of responsibility from the quality management. That is why it may occur for example, that the position of the QM-/RA-Manager is staffed with just one person. Then in addition to tasks from the Regulatory Affairs, further tasks such as maintaining the QM system or preparing and participating in audits (internal/external audits, supplier and document audits) are added. Thus, there are parallels between the two occupations.
Eventually, the Regulatory Affairs Manager has become a central figure in the field of medical technology. With the date of application of the new MDR just around the corner, this occupation becomes even more important and future chances to get started with this job are excellent.
Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.