I think the answer to this question is really based on where you want your career to end up. I have always been interested in people management. Befor...

When deciding between going with an S-Corp or C-Corp structure, one must carefully weigh the benefits of tax savings against broader opportunities suc...

Regulatory agencies such as the FDA and EMA, while governmental agencies, tend to operate similarly to non-profit organizations. They do not generate ...

I think this is a great topic to dive deeper into! I have experience in both, working in a research lab during my undergraduate studies and the corpor...

I had a role in a Performance Evaluation R&D Group during one of my Co-Ops. Although this role was in the R&D field, being performance evaluat...

Cybersecurity is certainly a vital consideration when migrating from paper-based to digital systems. Along with cybersecurity, another important facto...

Regulatory Affairs is a great field to explore. From my own industry experience and from speaking with hiring managers, there is always a high need fo...

I think post-market management may have a more significant long-term impact compared to product development. While both play important roles in projec...

You did a great job summarizing the FDA and CDRH's role in regulating medical devices. It is also worth mentioning that the approval process for Class...

Filing with multiple international agencies is a complex process. Harmonizing regulatory submissions across different countries is challenging, but ca...

While I do agree that regulatory consultants can be helpful in staying up to date with changes from the FDA and ensuring compliance, I would argue tha...

Most responses in this discussion bring up using other avenues to conduct clinical trials such as artificial tissues or bioreactors. While these are a...

Stability testing is certainly imperative for specific applications in the medical field. One specific product that I have not seen mentioned is sutur...

I certainly agree that when the project manager or PI is organized accomplishing tasks/projects becomes easier. Project managers who are on top of the...

I'm not a project manager just yet, but I have seen the stress that comes with the role of a project manager. I've been involved in a CAPA where multi...