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...

During my time in industry, I've noticed the necessity of time management in terms of project efficiency and effectiveness. I think this question is f...

Taking a medical device from its conception to delivering the device to patients is an area that I have recently become more and more interested in. I...

The majority of replies that I have read on this forum revolve around the importance of high GPAs losing their merit in today's day and age. While I d...