Medical Device Regulatory Affairs

Network Scientific have been providing our award-winning medical device recruitment agency services for over 10 years and always have a wide range of medical device jobs available to candidates looking to pursue a career in this field.

What is Medical Device Regulatory Affairs?

Regulatory Affairs in medical devices is essential to satisfy government’s requirements to ensure the safety and efficacy of medical device products to protect public health.

What do Medical Device Regulatory Affairs Professionals do?

The job of a regulatory professional is broad and covers all aspects of medical device development, manufacture and marketing from pre-market regulatory strategy through to device sale and post-market surveillance.

Jobs in medical device regulatory affairs can include:

• Regulatory strategy – to ensure that any device to be developed can be brought to market legally. For medical devices that will be sold overseas, knowledge of international regulations is also required. This information, and updates thereof, needs to be presented to Product Developers, Scientists and Senior Management regularly throughout the development process.
• Data management – the Regulatory department within an organisation is required to compile, collate and review lots of documentation and data to ensure compliance, therefore jobs in this field are especially suited to those individuals with a keen eye for detail; those who don’t mind spending lots of time reading and checking data. In addition, marketing applications and variations tend to have tight deadlines, so all of this can be required while under particular time constraints and pressure.
• Marketing Applications – After the device has been developed, the regulatory affairs department are responsible for compiling the marketing submission that that is required for the product to be legally sold within the chosen regions.

The job of a regulatory affairs professional requires constant professional development and continued learning as the regulatory landscape is ever-changing. You need to be willing to keep up to date with all legislative changes and developments throughout all of the regions in which your company sells its medical devices.

How do I Become a Medical Device Regulatory Professional?

Like most professions, this starts with your qualifications. We have seen graduates of many different degrees make it in a regulatory career but most have a scientific degree such as; Biochemistry, Chemical and Physical Science, Biomedical Science, Pharmacology, Pharmaceutical, etc.

While a Masters Degree is not essential, it can be beneficial. TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs and they offer an MSc in Regulatory Affairs and also offer a Basics of Regulatory Affairs course.

The Regulatory Affairs Society (RAPS) also offer a Regulatory Affairs Certification (RAC).

Regulatory affairs professionals are essential for ensuring product safety, not only for the medical device and medtech, but for others too, including; agrochemicals, biotechnology, cosmetics, food/nutritional products, herbal and homeopathic products, pharmaceuticals and veterinary products.

For more information about medical device careers and medical device jobs, get in touch, we would be happy to discuss this with you.