Her Story
About Hiral
She is a quality and regulatory affairs professional with experience in medical devices, regulatory strategy, compliance, product registration, competitive research, and cross-functional project support. She currently works as Lead Quality and Regulatory Affairs Specialist at Elucid. Previously, she held regulatory affairs roles with TeraRecon, Cardinal Health, and Open Avenues, and developed international regulatory strategies for medical device registration. She holds master’s degrees in Regulatory Affairs and Business Administration.
Her Interview
Ten minutes with Hiral
01What do you attribute your success to?
I think I've always found the best mentors in my career that have helped me grow and actually teach me important life lessons, be it professional or personal. The mentorship I've received is very valuable for me.
02What’s the best career advice you’ve ever received?
You need to be a very good communicator. If you're not able to express your thoughts clearly to people, however skilled you are, that's not going to help you in the long term or help you grow in your career.
03What advice would you give to young women entering your industry?
They should network with people because networking is important. I lacked there as I've been an introvert. Networking helps in the long run. Also, practical experience is important, especially for regulatory work. Theory is not enough; take whatever experience you get and learn from it.
04What are the biggest challenges or opportunities in your field right now?
The opportunities and challenges are AI in software. AI is trending and being used in softwares as medical devices. FDA has guidance on AI, and it's difficult to get AI med devices cleared. At my company we're working on an AI product, which is a great opportunity to understand how FDA works around AI devices.
05What values are most important to you in your work and personal life?
Being a hard worker but along with being a smart worker. Hard work does not always get you everywhere if you're not smart enough. People who are smart enough to navigate through everything reach a better level.
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