If you want to launch a new medical device on the market, there’s no getting around it: it’s hard to imagine medical technology without regulatory affairs. Especially since the approval process for a new medical device is sometimes the heart of the whole affair. In the meantime, there is also a separate job title for it: the Regulatory Affairs Manager. Because in today’s times, and especially under the new MDR, it is becoming increasingly important to know all the specifics of a medical device approval and to know exactly how this complex process works.
Regulatory Affairs – just another euphonious term?
Now let’s start from the beginning: the term Regulatory Affairs is widely used in the pharmaceutical/medical device industry and is used in connection with both pharmaceuticals and medical devices. It refers to the process of getting new medical devices or drugs approved and the guidelines that must be followed when going through this approval process. The job title of Regulatory Affairs Manager (RA Manager for short) is thus predominantly found in the fields of medical technology and the pharmaceutical industry, and there also sometimes at the interface with quality management. This article will take a closer look at the job description of the RA manager in the field of medical technology.
The tasks of a Regulatory Affairs Manager
The specific duties of an RA manager can vary by job and company, but often include the following elements:
Coordinating projects to implement MDR 2017/745 or IVDR 2017/746 and supporting the relevant departments in meeting regulatory requirements.
Accompanying development projects, creating development-related and technical documentation for medical devices, editing existing technical documentation
Communicate with the relevant regulatory authorities (national/international) and also with the Notified Bodies
Checking conformity (all approval documents must be compliant with all relevant regulations, directives and standards) and participating in the conformity assessment procedure with coordination of all departments involved
Contact point for colleagues in the company regarding all questions on technical documentation and approval of medical devices
Realization of employee trainings on the topic of Regulatory Affairs
Staying informed about any changes in legislation, etc.
However, in order to fulfill all these tasks, one aspect is of fundamental importance: A sound knowledge of the relevant regulatory guidelines, i.e. MDR, IVDR, MPG, relevant laws and guidelines, such as MEDDEV, applicable standards, etc.
Education? Study? How to obtain the appropriate qualification
To say it in advance: In Germany, there is no classical study program with exactly the title Regulatory Affairs. However, there is a good offer of (mostly part-time) continuing education or postgraduate courses. For the sake of completeness, it should be mentioned that the German Society for Regulatory Affairs (DGRA) exists, but it is primarily concerned with the approval of pharmaceuticals, which is not necessarily comparable with the approval processes for medical devices.
The regulatory affairs manager thus has a job description that is made up of various disciplines and components. However, job advertisements often require scientific or technical degrees as a prerequisite, sometimes in combination with adequate further training in the field of regulatory affairs. Depending on the company and the position to be filled, lateral entrants may also be welcome.
In addition to a university education, the following so-called soft skills are particularly beneficial for the position of Regulatory Affairs Manager:
Sense of responsibility
Reliability
High degree of diligence and accuracy in the way you work
Structured and goal-oriented action
communication skills
A perfect command of spoken and written German and English is now also a standard requirement; other languages are always an advantage. A few years of professional experience in the field of regulatory affairs at a medical device manufacturer are of course always welcome.
The required qualifications of an RA manager may vary from company to company and can be interpreted even more specifically in some cases, but ultimately the requirements can be reduced to a good common denominator.
Last but not least
In job advertisements, you can also often read that tasks from the area of quality management have to be taken over. In some companies, especially in small or medium-sized enterprises, the activities of the RA manager overlap with tasks from quality management. For example, it may happen that the position of QM/RA Manager is filled by one person. In this case, tasks such as maintaining the QM system or preparing for and participating in audits (internal/external audits, supplier and document audits) are also added to the Regulatory Affairs area of responsibility. There are therefore certain parallels between these two activities.
Ultimately, the regulatory affairs manager has become a central figure in the field of medical technology. With the new MDR coming into effect just around the corner, this job is becoming all the more important and the future chances of really taking off in this profession are excellent.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
