Hello everyone. I discovered this platform through Regulatory Affairs Leader at the company where I'm currently interning at, and I must say it's fantastic. Seeing so many experts gathered in one place, I thought I could get some advice for the next steps in my career. As a bioengineering student, I've interned in Quality Control and Quality Assurance departments within the pharmaceutical industry and in Quality and Regulatory Affairs departments for medical devices. I'm deeply interested in Quality and Regulatory Affairs.
I've completed training and obtained certifications for ISO 9001, 14001, and 45001, but I believe that without practical application, these certificates hold limited value. I have a general understanding of GMP, MDR, and ISO 13485 and am currently learning about the documentation processes at the company. Yet, I still feel there are gaps in my knowledge.
As my graduation approaches, I want to ensure I have a strong foundation in these areas. Could you share any advice, recommendations, or valuable lessons from your experiences? I don’t feel confident enough in my knowledge and am determined to change that. Additionally, I'm uncertain whether I should focus more on Quality Assurance or Regulatory Affairs. Any guidance to help me clear this confusion would be greatly appreciated. Thank you in advance for taking the time to respond