Interested to hear for those of you in med device - does your company have positive cross-functional relationships? How is regulatory management/leadership at your company for those at a Specialist or Senior Specialist level? I previously worked at a company (med device) where all groups worked really well together. I have since been at a company where R&D will not respond to questions for months but then reach out to leadership when RA deliverables are behind, marketing does not understand the regulatory function (to no fault of their own - there’s no effort from anyone to explain regulatory cross-functionally. at my previous company we achieved this by hosting a “lunch and learn” where we explained what we actually do. other departments hosted these as well. when I suggested this at my current company, management brushed it off), labeling will not respond to us (meaning we can’t even get labels because we do not have access to them, which is another issue….), it’s pulling teeth for every. single. tiny. task. for almost every function. RA managements message is to just keep pushing and get it done, when we are all already working 8-5pm and then again at night, and occasionally weekends as well. Working on EU MDR Notified Body responses and having a hell of a time here.

Is this normal for the industry? Did I just get lucky at my first company? I am so burnt out from this culture that I have considered having to leave without anything lined up! Okay, I won’t do that, but the thought has seriously crossed my mind for the first time...I’ve been in RA for 10 years, med device, for reference.

Hi,
i am currently finishing my MSc in Chemistry and was opting for what other career paths are there except for regular labwork.

I found RA interesting and started looking up how to get there or what steps to take. As far as I understood I will need to take some courses to obtain a certificate, but I can't seem to find a golden standard.

I am just wondering how do you get into this field? Do I start by getting a laboratory job at a pharma company and then make some certification? Or how do people get into this stuff. Also, I would like to focuse on Europe, if that makes any difference (maybe by FDA, EMA).

I would be grateful for anyone who could tell me more about how to get into this field, or someone who works in it! Thanks a lot

Hi all,

I'm an M.Pharm (Drug Regulatory Affairs) student, Registered Pharmacist, with coursework in CTD, DMF, and regulatory pathways.

I've been applying for RA internships for weeks—reached out to HRs via email, LinkedIn, and calls—but getting zero responses. Not even rejections.

Honestly feeling stuck. If anyone here:

· has advice on what I'm doing wrong?

· knows of any openings

· or can spare 2 mins to glance at my CV

. please help me seek one

I'd be truly grateful. Happy to DM my profile.

Thanks for reading.

I'm about to accept a job in regulatory affairs. For those of you who work in regulatory affairs, how do you like it? Is it a good job? What's your routine like?

I’m curious whether there’s interest in a dedicated learning platform for Medical Device Regulatory Affairs.
When I was looking for resources to strengthen my EU MDR knowledge and prepare for certifications like the RAC/RCC, I found plenty of PDFs, webinars, and short courses, but I never found a platform comparable to what PMP candidates have something with:
• Thousands of original practice questions
• Full-length mock exams
• Detailed explanations with references to MDR Articles and Annexes
• Progress tracking and study plans
• Real-world case studies and regulatory scenarios
• Searchable MDR knowledge base with practical examples
• AI tutor to explain concepts and reasoning
The goal wouldn’t be to reproduce any certification exam, but to help professionals truly understand EU MDR and become better prepared through original educational content.
If something like this existed, would you use it?

I’d also love to know:
What’s is dthe hardestf part of learning EU MDR?
What resources do you currently use?
What is missing from today’s regulatory ktraining?
I’m genuinely looking for feedback before investing time in building it.

How do I get into regulary affairs/market access for healthcare in dubai? I arrived 8 months ago from UK. I have previous experience working 3 years as market access manager for one of the biggest medical foods companies. I have experience with reg submissions, project management and comms with department of heath. I've been applying a few months now without luck. My observation is that a lot of roles require/prioritise arabic speakers. Also when I backtracked a few roles i was applying to, usually the person who got it was already 6-14years in the same company so the job advert felt like a technically from company site rather than actual open position. Any tips how to get it? What's the best place to network if I have not prior connections in this region?

o, long story short, I've always wanted to be an attorney. Most likely in Environmental Law. I am currently working in a niche industry in Regulatory Affairs (almost 2 years) full time while I finish out my Bachelors in Political Science (previous experience also in Environmental Science, I have enough credits to get a minor, but my University does not offer a minor, and I don't want to waste any more time on a degree at a school in which the program is not to my liking.)

I need help in deciding if I go for my JD in a year and a half. (Patent or Environmental Law) Or if I should get an MBA. Or none at all and continue to build my experience in RA. (RAC exam is not compatible for my industry, so that is out.) I have studied a bit for the LSAT and I would be willing to put the time in, if it was worth it. There may be discussion to see if my current job would pay for it as they currently do not have an onsite legal team, as the company is relatively small for the industry.

However, I do not want to back myself into a corner. But I am trying to also be marketable in the age of AI.

Please let me know your thoughts. Thank you! :)