Making Your Voice Heard in Regulatory Affairs With Hasnaa Fatehi

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Regulatory professionals are sometimes sidelined within companies, and labeled as barriers to innovation and profit. In this edition of Consultants Corner, QARALOGIC’s Hasnaa Fatehi discusses how regulatory affairs specialists can better frame their role in the context of a company’s commercial priorities and be relied on as a partner in market success.

Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.

 Hasnaa Fatehi, PhD, runs QARALOGIC, a consultancy that supports medical device company regulatory clearance strategies in Europe, Asia, North America, and other markets. Fatehi has previously served in regulatory positions at multiple device companies. She has a background in biomedical engineering, mathematical biology, and fine arts.  

The Question: Why Aren’t My Business Leaders Listening to Me?

Regulatory affairs is a crucial part of how the medtech ecosystem operates, but too often the role doesn’t hold a badge of honor and respect within companies, Hasnaa Fatehi laments.

“There's this culture that if you sit with R&D, they hear regulatory and the understanding is you're not creative, you're just a paper pusher and you don't understand innovation, that you're stifling innovation,” Fatehi said in an interview.


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