Regulatory Affairs: The Most Underrated Healthcare Career Students Should Know About

When a new drug or medical device is introduced, it is not approved by innovation alone. Behind every successful healthcare product is a Regulatory Affairs (RA) team that ensures it meets national and global standards before reaching patients. Despite its critical importance, Regulatory Affairs remains one of the most underrated career paths in healthcare — especially among students.

What is Regulatory Affairs?

Regulatory Affairs professionals act as the bridge between scientific innovation and patient safety. Their role is to ensure that medical products comply with laws, guidelines and quality standards set by regulatory bodies.

In healthcare and MedTech, this includes:

• preparing regulatory submissions
• interpreting national and international guidelines
• coordinating with quality and clinical teams
• ensuring compliance throughout a product’s lifecycle

Without Regulatory Affairs, even the most advanced technology cannot reach the market.

Why Regulatory Knowledge is in High Demand

Healthcare regulations are becoming increasingly strict worldwide. Medical devices, for instance, must comply with international standards such as ISO 13485 and follow robust Quality Management Systems (QMS).

Ms Manisha Chauhan, an alumna of Apeejay Stya University and an industry professional working in the MedTech sector shares, “Students should mainly focus on regulatory knowledge because this is what the medical device industry requires.”

This growing emphasis on compliance has created a strong demand for trained regulatory experts across pharmaceutical companies, medical device manufacturers, and research organisations.

How Students Can Enter Regulatory Affairs

Regulatory Affairs is well-suited for students from science backgrounds, including biotechnology, life sciences, pharmacy, and clinical research. Postgraduate programmes in Clinical Research often introduce students to:

• regulatory frameworks
• clinical trial phases
• quality control and assurance
• documentation and reporting

This makes them well-prepared for entry-level regulatory roles.

Career Growth and Opportunities

Regulatory professionals work in:

• pharmaceutical and medical device companies
• hospitals and research centres
• regulatory consultancies
• global healthcare organisations

With experience, they can advance into leadership roles overseeing compliance strategies for multiple regions — making this both a stable and rewarding career.