Outdoors Enthusiast, Regulatory Expert, Collaborator
When you think of life-saving medical breakthroughs, your mind might go straight to scientists in labs or doctors in hospitals. But behind many of these innovations is someone like Katrina, a Regulatory Affairs Specialist at ARMI, the Advanced Regenerative Manufacturing Institute, who helps make sure curative therapies actually reach the people who need them. Her role may not involve a lab coat or scalpel, but it’s just as vital. ARMI is the parent organization of the Manufacturing USA institute, BioFabUSA.
Katrina began her journey with a Bachelor of Science in Biotechnology from the University of New Hampshire in 2019. From intern to Regulatory Affairs Specialist, her rise at ARMI was powered by a unique blend of technical expertise and people-focused collaboration. She’s worked across a variety of complex medical product areas—think regenerative medicine, tissue engineering, cell therapy, and related technologies—ensuring that every step toward market readiness is safe, strategic, and compliant.
Her work touches nearly every part of the product development lifecycle. Whether she’s preparing FDA meeting requests and submissions, leading regulatory strategy sessions, or helping shape international standards, Katrina brings both precision and perspective. She also plays a key educational role to industry and beyond, distilling regulatory guidance and speaking at workshops to share her knowledge and perspectives on the still young but maturing regenerative medicine industry.
Katrina’s impact doesn’t stop at driving standards initiatives, regulatory submissions, and strategy sessions. She’s a mentor and educator, actively engaging with students and young professionals to spark interest in biofabrication careers. Her presence—whether in a classroom, on a conference stage, or even at a local Brickyard Banter Toastmasters meeting—reflects a rare mix of poise, technical skill, and passion for patient-centered innovation.
Katrina’s career path is a blueprint for anyone looking to make a meaningful difference behind the scenes of biotech advancement. For this, Katrina is a Modern Maker.
Q&A with Katrina
How did you find your way to working in advanced manufacturing?
I consistently researched "biotechnology jobs" and considered internships as a priority throughout my undergraduate education, worried that a lack of exposure to a certain area might cause me to miss out on finding my niche. This approach reflected my natural tendency towards being a jack of all trades and filling the "figure it out" role on a team, always excited to jump into an unknown.
I focused on creating as many opportunities for myself as I could to obtain as much exposure and experience as possible. I applied myself in my studies, networked, volunteered in clubs and conferences, sought positions as a Teaching Assistant (TA), and applied to internships in industry. After hearing about the exciting work happening at ARMI, I was immediately hooked on their mission to cure rather than treat medical conditions.
With family members suffering from different chronic diseases, I wanted to contribute to this mission in any way I could. I volunteered to assist in the execution of one of ARMI’s first regenerative medicine conferences (formerly "Summits", now "Meeting in the Millyard"), then applied to and interviewed for each summer internship position posted, ultimately landing a position as Regulatory Intern. This ended up being a natural fit for me because, while unbeknownst to me at the time, the very nature of the traits I mentioned at the start set me up for success at ARMI, where we constantly play with the unknown and challenge traditional approaches to product development and regulation to fit novel regenerative medicine products within the flexibilities inherent to the existing framework.
What is the most challenging part of your job?
There is no precedent for ARMI's work and few standards to follow. We are pioneering the way for novel medical products and cures to reach patients in need, bridging the gap between academia/discovery science and industry/commercialization. This means that we, as an organization, are operating in a space that few have trod and therefore must think critically and creatively every day to work towards solving problems and bringing light to the unknown.
What is the best part of your job?
Alongside the knowledge that I am helping patients receive the safe and effective therapies/cures they need, realizing that my work contributes to the efforts to solving the challenges inherent within the regenerative medicine space is a very rewarding aspect for me. I love strategy and the feeling of accomplishment knowing that I have made a dent in understanding the unknowns, driving the field forward.
However, ultimately witnessing ARMI’s incredibly knowledgeable team of teams collaborate is the absolute best part of my job. I have never known an organization to be filled with such hardworking, mission-driven individuals. Working alongside them keeps me inspired!
What would people be surprised to learn about manufacturing or your role in manufacturing?
Regulatory affairs is truly a jack-of-all trades, cross-functional role. To be effective in this position, you must have robust regulatory knowledge, a strong understanding of the science/engineering that goes into product development, good interpersonal and communication skills, technical writing skills, and creativity to think out of the box and form intriguing narratives. It is a fun, never-ending cycle of learning and teaching!
What advice do you have for someone new to the industry or considering manufacturing as a career?
Don't be afraid to ask questions or try something new! Despite what you may think, no one knows everything, and the only way to gain experience is through doing and learning from each other. However, while my default is to open yourself up to learn something new, I also want to note that there is still a place for the "fake it until you make it" attitude. This have provided me with some added confidence when needed, which has gone a long way in networking, public speaking, leading projects/meetings, and stepping into some leadership roles.
What makes you excited to go to work on Mondays?
Stepping into work on Monday can be akin to "stepping into the unknown". While I always have an understanding of what the day will look like (e.g., meeting schedule), I never know what new, exciting questions I will be presented with to dive into and figure out. A lot of the "figuring out" is also done collaboratively during BioFabConsulting's weekly team meeting. Here, I have the opportunity to report out on my clients' needs, status, and suggested solutions/strategy and receive team feedback.
What are the three most important skills for your job?
- Written communication skills
- Critical thinking skills, like being able to consider out-of-the-box solutions and new approaches to traditional ways of thinking and doing
- Intellectual curiosity science and regulatory landscapes are dynamic!
If you didn’t have to work, how would you spend your day?
Being outdoors with my dog, boyfriend, and family. We love hiking, particularly around the White Mountains in NH. I have hiked all of the NH 48 4,000 footers and most of the NH 52 with a View with my siblings. Truly, any outdoor adventure!
I also love learning new languages and hoop dances, which is a form of dance/flow art.
What activity gives you the most energy?
Spending quality time doing something active with my loved ones refills my battery.
What hobbies make you better at your career?
My love of hiking and learning both push me further in my career. Challenges inherent with hiking has been most practical in forcing me to apply the mind over matter concept, showing me that I can harness the power of the mind to control and influence my actions to stay focused and dedicated during a difficult project. Constant learning, such as with new languages, has been shown to boost creative thinking, problem-solving skills, and mental dexterity.
How does the work you do impact the world?
Regulatory Affairs professionals play a crucial role in advancing safe and effective medical products through the regulatory framework to patients in need, ultimately bringing innovative therapies and cures to market to improve patient outcomes and transform healthcare.
By navigating ARMI and client projects through complex regulatory landscapes, I am working to help set the regulatory precedent for tissue-engineered and regenerative medicine products, therefore streamlining the approval process for the future of medicine and ultimately enhancing the quality of life for patients who might otherwise have limited treatment options.
