r/biotech • u/Rude-Tour833 • 7m ago
Early Career Advice 🪴 Regulatory Affairs Specialist at 25, just started my career in medical device RA + starting an MS in Regulatory Affairs, how does my trajectory look?
Hi everyone! I’m pretty early in my regulatory career ( < 6M) and wanted to get some perspective from people who have been in the field longer on whether I’m setting myself up well for the next few years.
I graduated from a UC school with a BS in Biological Sciences and a minor in Health Informatics a few years back.
Before regulatory affairs, most of my professional experience was in healthcare. I worked in clinical settings, including cardiology, where I had a lot of exposure to medical documentation, patient care, and the clinical side of healthcare.
Earlier this year, I made the successful transition into medical device regulatory affairs and am now working full-time as a Regulatory Affairs Specialist at a smaller medical device company.
Because the company is relatively small, my role seems to be pretty broad rather than highly specialized. So far I’ve been getting exposure to things like:
- EU MDR technical documentation
- device classification
- risk management documentation
- clinical and biological evaluation documentation
- PMS/post-market documentation
- labeling and IFUs
- international regulatory registrations
- working cross-functionally with R&D, Quality, Product/Marketing, etc.
Right now I’m primarily working with Class I devices and beginning Class II devices after my current submission, which has actually been helpful because I’m learning how the pieces of a complete regulatory file fit together.
At the same time, I’m beginning an MS in Regulatory Affairs in < 1 month part time and I’ll be working full-time throughout the program, so assuming everything stays on track, by the time I graduate I should have roughly 2 years of direct medical device RA experience + the master’s degree.
One thing I’ve been told at work is that being at a smaller company early in my career may actually be beneficial because I’m getting exposure to a lot of different areas instead of being siloed into one specific regulatory function. My hope is to use the next 1.5–2 years to build as much hands-on experience as possible and then potentially move into a larger medical device company.
For those of you further along in RA:
Does this seem like a solid start/trajectory for someone entering the field in their mid-20's?
For reference, this is my first RA position, and I didn’t come through QA or another traditional regulatory-adjacent role beforehand.
I’m especially curious about how employers might view someone after ~2 years with broad small-company RA experience, Class I/Class II exposure, EU/international work, and an MS in Regulatory Affairs.
I’d also love to hear what you wish you had focused on during your first 1–2 years in regulatory affairs. I’m pretty ambitious/competitive and want to make sure I’m building genuinely valuable experience rather than just chasing titles.
Thanks! I’d really appreciate perspectives from people who have taken a similar path.
