u/Rude-Tour833

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 a few years ago with a BS in Biological Sciences and a minor in Health Informatics.

Before RA, most of my experience was in healthcare/clinical settings, mainly cardiology, so I had a lot of exposure to medical documentation, patient care, and the clinical side of things.

Earlier this year I transitioned into medical device RA and now work full-time as a Regulatory Affairs Specialist at a smaller device company.

Since the company is fairly small, my role is pretty broad. So far I’ve gotten exposure to EU MDR technical documentation, device classification, risk management, clinical/biological evaluation documentation, PMS/post-market documentation, labeling and IFUs, international registrations, cross-functional work with R&D, Quality, Product/Marketing, etc.

I’m currently working mostly with Class I devices and should be moving into Class II work shortly after my current submission.

I’m also starting an MS in Regulatory Affairs soon and will be doing it part-time while continuing to work full-time. Assuming everything stays on track, I should graduate with around 2 years of direct device RA experience along with the master’s.

A few people at work have told me that starting at a smaller company can be a good thing because I’m getting exposure to a lot instead of being siloed into one area. My plan right now is to spend the next 1.5–2 years learning as much as I can, then potentially try to move into a larger med 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-20s?

This is my first RA job, and I didn’t come through QA or another regulatory-adjacent role beforehand. I’m especially curious how larger companies would view someone with ~2 years of broad small-company RA experience, Class I/Class II exposure, EU/international work, and an MS.

I’d also love to hear what you wish you had focused on during your first 1–2 years in the field. I’m pretty ambitious/competitive and want to make sure I’m building experience that will actually be valuable long-term rather than just focusing on titles.

Thanks! Would really appreciate any advice/perspective.

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 a few years ago with a BS in Biological Sciences and a minor in Health Informatics.

Before RA, most of my experience was in healthcare/clinical settings, mainly cardiology, so I had a lot of exposure to medical documentation, patient care, and the clinical side of things.

Earlier this year I transitioned into medical device RA and now work full-time as a Regulatory Affairs Specialist at a smaller device company.

Since the company is fairly small, my role is pretty broad. So far I’ve gotten exposure to EU MDR technical documentation, device classification, risk management, clinical/biological evaluation documentation, PMS/post-market documentation, labeling and IFUs, international registrations, cross-functional work with R&D, Quality, Product/Marketing, etc.

I’m currently working mostly with Class I devices and should be moving into Class II work shortly after my current submission.

I’m also starting an MS in Regulatory Affairs soon and will be doing it part-time while continuing to work full-time. Assuming everything stays on track, I should graduate with around 2 years of direct device RA experience along with the master’s.

A few people at work have told me that starting at a smaller company can be a good thing because I’m getting exposure to a lot instead of being siloed into one area. My plan right now is to spend the next 1.5–2 years learning as much as I can, then potentially try to move into a larger med 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-20s?

This is my first RA job, and I didn’t come through QA or another regulatory-adjacent role beforehand. I’m especially curious how larger companies would view someone with ~2 years of broad small-company RA experience, Class I/Class II exposure, EU/international work, and an MS.

I’d also love to hear what you wish you had focused on during your first 1–2 years in the field. I’m pretty ambitious/competitive and want to make sure I’m building experience that will actually be valuable long-term rather than just focusing on titles.

Thanks! Would really appreciate any advice/perspective.