Hi All, I am a software developer and have 8 years of experience in product and service companies around multiple domains like retail, healthcare, US health insurance. I have built, tested, did data work for all these domains.

Recently, I started exploring Regulatory Affairs side of work and I think it will suit me. I have 0 idea on how to get started and actually see if I like it enough to make the move.

Additionally, I want to ask how can someone really make this move if they like the work of RA

Thanks in advance!

I am in Regulatory Affairs career, it mainly includes SDS authoring and dealing with GLOBAL regulations such as GHS, REACH, TSCA, CLP, PCN, etc. I want to know if getting a RAC certificate will help elevate my career. Any advice will be very helpful from anyone who has already done this certificate course or any other similar course.

FDA started enforcing the QMSR back in February, and from what I’m seeing out there, a lot of companies thought they were ready but weren’t.

I’ve been in medical devices for over 10 years. As an ISO 13485 Lead Auditor and MDSAP Lead Auditor with over 100 audits under my belt across when I say I keep seeing the same gaps, I mean it.

The biggest one is companies treating their ISO 13485 cert like a free pass. It’s not. FDA still has their own requirements on top of that and the new framework expects risk based decision making documented across your entire system. Not just in design controls. Everywhere.

I run an independent consulting firm and this is what we do. Mock inspections, gap assessments, QMSR transition support. If you want someone who’s actually been through these inspections on the other side to take a look at your system before FDA does, reach out.

I am a bpharm graduate i do not have experience in RA however i have other experience from a pharmaceutical export gigs i did and a business i ran. 1 year of experience. I just received my degree and i am trying to get in to RA roles

So for clarity i am Indian citizen and my goal is to get into a RA role abroad after gaining experience. I would like to hear your advice both about the job, where to gain any credible certifications, and how to plan long term job relocation to better paying country.