NOMSA
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.
​
Dr. Niedre M. Heckman leverages 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.
-
Freelance writer specializing in regulatory, medical, and technical/engineering content. Provide educational consulting and public speaking on public health topics, with a focus on social determinants of health and diversity, equity, and inclusion.Freelance writer specializing in regulatory, medical, and technical/engineering content. Provide educational consulting and public speaking on public health topics, with a focus on social determinants of health and diversity, equity, and inclusion.
-
Technical Writing • Ghostwriting • Diversity & Inclusion • Public Speaking • Training • Educational Consulting • User Experience Writing
​
Yellow Owl Publishing
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.
About Niedre Heckman
From the earliest days of her childhood, Niedre Heckman always felt as though she was living between worlds. As a Black woman born with white skin, her journey has been one of perpetual discovery and introspection, a quest for identity that led to the creation of her memoir, The World Where I Belong: My Quest for Identity As a Black Woman in White Skin. Throughout her life, she has faced the duality of belonging everywhere and nowhere, a complex experience that shaped her views on culture, race, family, and community. Her story resonates with anyone who has struggled with the question of identity, and her writing seeks to build a bridge for others in search of their own sense of belonging.
As we grow, we will send out emails with news and events. If you would like to be added to our list for future information, please use the form below.