Niedre Heckman
Director of Regulatory Affairs Strategy with over 20 years of experience in FDA-regulated industries, specializing in global regulatory strategy for combination products, medical devices, and biologics.
I leverage deep business acumen alongside regulatory and scientific expertise to develop and execute high-quality, first-time-right regulatory filings for complex medical devices and drug/biologic-device combination products. By anticipating reviewer questions and embedding clear, data-driven responses in dossiers, I consistently reduce review times and limit review cycles. My approach has earned written commendation from FDA-CDRH for exemplary regulatory filing quality.
With a PhD in Public Health, an MPH in Community Health Sciences, and an MS in Chemistry, along with certifications in Quality Auditing and Regulatory Affairs (US and EU), I am well-equipped to drive regulatory success. My track record includes authoring and submitting a broad range of regulatory submissions (510(k), BLA, CBE-30, IND, NDA, PAS, PMC, and annual reports) and receiving the FDA-ORA Leveraging Collaboration Award for advancing compliance communication platforms.
A TEDx speaker and dedicated medical writer, I am passionate about educating and inspiring others on the role of regulatory affairs in advancing public health.
New Release
The World Where I Belong
If you've ever felt like you didn't belong in this world because of a norm you didn't fit into, this book is for you.
What do you do when people are moved with compassion and courage to share their stories after you've delivered your first TEDx talk? This is the question Niedre Heckman faced after she delivered a powerful keynote about the opportunity we all have to promote positivity in our uniqueness rather than spinning a negative narrative about those who seem not to fit the norm. As Niedre thought about the impact of those 9 minutes, she felt like there was so much more to say that really could help people. This led her to write a memoir.
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