Seeking Guidance

[sinem]

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

 

[Mike S.]

So get a job in pharma. Any job, even of not your ideal job (it likely won't be). Keep your eyes open for other opportunities but excel at whatever job you have. Your path will become clearer.

 

[Cristiann]

the experience is very important in your position, as soon as you graduate as above Mike mentioned you should seek for a job even though its not your dream job. I know in Turkey sometimes this process is very hard to step in some company. But I know many of my friends after they graduate they just didnt give priority on this topic and now they regret about this.

Other than that you will understand after graduation you will need to have some abilities in terms of communication.

Good luck.

 

[Mike S.]

The OP posted once and not since.

 

[Randy]

The OP posted once and not since.

The OP was probably phishing

 

[david7763]

Consider certifying (or at least learning) ISO/IEC 17025 for test & calibration labs. But to determine whether you should focus on QA or Regulatory, there's one simple question: What were you doing the last time you completely lost track of time for several hours? Whatever you were doing (as long as you were awake), it was engaging your passions and that's what your career should do. Figure out what part of your passion was piqued and engaged by that activity, then pursue your passion!

 

[sinem]

So get a job in pharma. Any job, even of not your ideal job (it likely won't be). Keep your eyes open for other opportunities but excel at whatever job you have. Your path will become clearer.

i know that my first job wont meet my expectations but i hope i can make a good start. thanks for your reply.

 

[sinem]

Consider certifying (or at least learning) ISO/IEC 17025 for test & calibration labs. But to determine whether you should focus on QA or Regulatory, there's one simple question: What were you doing the last time you completely lost track of time for several hours? Whatever you were doing (as long as you were awake), it was engaging your passions and that's what your career should do. Figure out what part of your passion was piqued and engaged by that activity, then pursue your passion!

Embarrassingly and sadly, I must admit that I gave up searching for my passion a long time ago...
I just want to become a qualified professional in what I do and achieve something along the way. Later, as I taste the success, this might turn into a passion. What do you think? But I hadn’t received many comments at university or in the industry that reminded me of my passion. Yours made me happy, thank you

 

[sinem]

the experience is very important in your position, as soon as you graduate as above Mike mentioned you should seek for a job even though its not your dream job. I know in Turkey sometimes this process is very hard to step in some company. But I know many of my friends after they graduate they just didnt give priority on this topic and now they regret about this.

Other than that you will understand after graduation you will need to have some abilities in terms of communication.

Good luck.

As someone who wants to be part of an international company, I’ve heard how different even the Turkish branch of a company can be compared to other countries. It will be challenging, but I hope I can succeed! Thank you for your reply )

 

[sinem]

The OP was probably phishing

Sorry?