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  • Tiyese Jeranji

Becoming a Regulatory Affairs Professional: 5 STEPS

Regulatory Affairs (RA) professionals play an important role in the medtech industry yet they are not so often heard of. The role of the RA professional in a company is to ensure that healthcare products are in compliance with regulatory requirements - a key aspect of market access. A career in Regulatory Affairs can be a fun and rewarding profession but how one ends up there is not so clearly cut out.

Become a RA in these 6 steps.

1. Be in the right field

Since the road is not clear cut, being in the right field is advantageous. Programmes that may set you off into this profession include biology, chemistry, pharmacology or technical science. Many of the RAs possess undergraduate degrees in engineering, clinical sciences, or public health. Others begin in totally unrelated areas such as business, economics, liberal arts and law.

2. Gain experience in the field

Experience is the best teacher, as cliché as it might sound. Bein a RA means that you have to gain experience in the field. Gaining field experience allows you to apply your regulatory knowledge to real-life projects. The easiest way to get experience is to work or intern for a medtech company while exposing yourself to all aspects of RA from license submissions, to regulatory research to the application of standards and regulations. There's a lot of reading and writing involved, so while you’re at it, learn to communicate effectively and improve your writing skills.

3. Do advanced coursework

With practical experience in the bag, it is useful, but not mandatory, to do advanced coursework that will bridge the gap between what you studied and what you want to do in RA. While there is a multitude of coursework and advanced degrees, some areas of interest could be in clinical research, food safety, regulatory science or health services. Some more targeted degrees include Masters in Regulatory Affairs.

4. Get certified

To show some industry-level credibility, you may consider getting various certifications to demonstrate your competency. With the field constantly changing, being certified enables employers to easily gauge a candidate’s knowledge base.

According to the Regulatory Affairs Professionals Society (RAPS), earning a Regulatory Affairs Certificate credential requires knowledge of healthcare product regulations, and the analytical and critical thinking skills to apply them in practice.

The certification you pursue will depend on your level of experience and your interest. For example, if you are interested in auditing and quality assurance, you should consider ISO 13485 auditor certification. Certification can be obtained through organizations such as BSI and RAPS.

5. Join a professional society

Since RA has no path to follow like going to a medical or law school, find a network of like-minded professionals who will help you advance your career. They will share experiences and techniques that will help shape your professional trajectory. Get involved with mentors and groups to strengthen your network.

If you're interested in learning more about the RA professional, contact us!

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