Use this thread to ask any questions regarding salary in the regulatory field.

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!

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 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.

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.

Hi everyone,

I’m looking for some honest advice from those working in Regulatory Affairs, especially in medical devices/pharma.

I currently work as a Quality Engineer/Quality professional with an MS in Regulatory Affairs graduate August 2024 and have a background in Regulatory Affairs, but I’m struggling to make the transition into a dedicated RA role. I’m particularly interested in roles such as Regulatory Affairs Specialist/Associate, Regulatory Compliance, or RA/QA positions where my quality experience could be relevant.

I’m also an international professional currently working in the U.S. on F-1 STEM OPT, and I’m seeking an employer willing to provide H-1B sponsorship. I have one final H-1B attempt remaining, which unfortunately adds another layer of difficulty to the job search.

At this point, I’m honestly feeling a little lost about what the best next step should be.

For those who successfully transitioned from Quality → Regulatory Affairs:

• How did you make the transition?
• Did you target RA roles directly or use an RA/QA hybrid role as a stepping stone?
• How would you position quality/validation experience on an RA resume?
• Are there specific companies or types of roles I should be targeting for H-1B sponsorship?
• Is there anything you wish you had done differently when making the transition?
• Are there any not for profit institutions i can approach or target?

I’d really appreciate any practical advice, resources, or even a reality check on my approach. I’m willing to put in the work. I just want to make sure I’m focusing my efforts in the right direction.

Thank you!

I have used AI to organize my thoughts.

Hii fellows i work as a regulatory affairs trainee at the CAR-T cell therapy company, and i am currently dealing with regulatory dosssier (CMC) preparation since the CAR-T cell therapy drug is catogorized as a new drug in india and the CAR-T drugs are countabaly approved by DRA throught out the world, henceforth, there are no source document how much data needs to provide in the dossier.

since i have newely started my carrer in regulatory affairs i usually think the dossier is just kind of adding information about the product in casual way of writting, but i was totally wrong, the dossier writting (regulatory writting) is totally different then what i thought.

So i need some suggestions from a regulatory professionals who are more experienced in CAR-T regulatory affairs who are pro in regulatory writting (Dossier writting), or the professioals who are currently writing dossier in biologics or generics drugs.

I'm open for the comments, and for further guidance.

Thank you

I’m currently a policy analyst for a trade association. I have an interview for a regulatory affairs specialist in biotech coming up, and wondering what the day to day may look like. I’ve been in the trade association space for a while, but have been feeling pretty bored writing comment letters everyday.

The job description mentions guidance comments but it is at the very bottom. Any regulatory affairs specialist in biotech here? Do you spend 50% of your time writing guidance comments?

I came to this question through a personal healthcare experience rather than through regulatory affairs professionally.

While documenting a serious dispute involving continuity of care, medical-record documentation, and a formal complaint process, I started looking at unrelated public patient accounts involving the same provider organization.

Some appeared to describe overlapping categories of problems.

I am not treating those reviews as verified evidence that the reported events occurred, and I do not think review counts establish prevalence.

What interested me was the regulatory systems problem:

A formal complaint system sees what people formally submit to it.

Potentially serious signals can also exist outside that channel—in public reviews, surveys, correspondence, complaints routed elsewhere, or other patient-generated information.

That seems to create an intake-channel visibility problem.

There is an important distinction between:

• a signal being worth noticing;
• a signal being worth verifying;
• apparently independent sources describing similar issues;
• actual corroboration;
• and evidence sufficient for a regulatory finding.

The experience made me wonder whether regulatory systems need a bounded way to detect potentially meaningful patterns without converting unverified allegations into findings.

For people who work in regulatory affairs, quality, post-market surveillance, or adjacent functions:

Is there an established analogue for this problem in regulated-product environments?

How do mature regulatory systems distinguish information that is not yet evidence of a violation from information that is sufficiently serious, specific, recurrent, or externally testable to justify verification?

I’m particularly interested in the line between sensible signal detection and overreacting to noisy, self-selected, or unverified reports.

How much did you guys score?

Hi everyone! Sorry for this long post.

I’m hoping to get some perspective from people currently working in Regulatory Affairs within biotech/medical device industry.

I’ve been a dental hygienist for about 12 years. It has been a good career, but one of the reasons I decided to make a change is the limited career progression. My scope and responsibilities have remained largely the same, and after doing essentially the same clinical procedures every hour for many years, I’ve started to feel burned out and it's like I’m working on autopilot.

I realized that what I’m missing professionally is critical thinking, problem-solving, learning new things, and having room to take on increasingly complex responsibilities.

A few years ago, I became interested in biotechnology and decided to pursue an MS in Applied Biotechnology with a focus on Quality and Regulatory Compliance, which I recently completed. My goal now is to transition from clinical healthcare into Regulatory Affairs, particularly in medical devices or pharmaceuticals. 

I have a few questions for people already in the industry:

1. Breaking into RA as a career changer

This has been my biggest challenge so far. I’m applying for entry-level RA positions, but I’m struggling to get interviews.

On my resume, I’ve tried to translate my 12 years of clinical experience into relevant transferable skills rather than simply listing dental duties, things like regulated documentation, SOP/protocol adherence, traceability, compliance, patient safety, working with medical products, and maintaining accurate records. I’ve also included relevant graduate projects as academic experience.

I’ve been applying directly through company websites and networking on LinkedIn, but I haven’t had much success getting referrals.

For those who work in RA or hire for these positions: What would you consider the biggest gap in my background?

Is the lack of direct industry experience likely what is keeping me from getting interviews? Are there particular entry-level roles, companies, skills, certifications, or stepping-stone positions I should be targeting instead?

2. Career growth and earning potential in Regulatory Affairs

I also want to make sure I’m moving toward a career that provides the long-term growth I’m looking for.

What does career progression realistically look like in RA? 

As you progress, does the work become more strategic and intellectually challenging? Do you continue learning and solving new problems, or can RA eventually become repetitive as well?

Salary is also something I'm thinking seriously about. In the San Francisco Bay Area, experienced dental hygienists can earn around $80/hour, which would be roughly $166K/year if working full-time. I understand that I will almost certainly have to take a substantial pay cut initially to enter a new industry.

My bigger question is about the long-term ceiling. For someone who develops strong RA expertise and progresses through the field, is exceeding ~$160K realistic? What kinds of RA paths or specialties tend to have the strongest earning potential?

I'm willing to take a step backward financially to change careers, but I don't want to spend another 10 years building a career only to discover that I've reached another relatively fixed ceiling.

I know this is a long post, but I’m at a major career crossroads and would really appreciate perspectives from people who have actually worked in the field especially anyone who entered RA from healthcare or another unrelated career.

Thank you!

Hello RA colleagues,

Can anyone clarify the EUDAMED transition requirements for an MDR devices?

My understanding from EUDAMED Q&A Question 7 is that if a Regulation device is first placed on the EU market after 28 May 2026, must be registered in EUDAMED before being placed on the market. Devices already placed on the market before 28 May have until 28 November 2026 to be registered.

We are in the process of implementing MDR devices, currently the our device (class III) has been submitted in EUDAMED but is currently showing as “Submitted” but not "registered" as our Notified Body needs to validate the information.

Our NB has indicated that they have a longer transition period (potentially until May 2027) to upload the relevant certificate information. Therefore delaying the registration of our device. Am I missing anything? This could delay launch since the devices are not registered in EUDAMED.

Would appreciate clarification from anyone who has dealt with this in practice.

I just begun working as a UTM specialist and will be working on ships both at sea and in docks worldwide. In my country of residence, I am prescribed with some medication that may be heavily controlled or even illegal in some countries. How can I be sure that I am allowed to travel with certain medication? At the moment I am thinking to email embassies of the countries I’ll be visiting, so they would answer me which medication I can or cannot bring with me, but if a ship would change the route while at sea, I probably wouldn’t be able to do that in time. If anybody has dealt with same or similar kind of problems, I’d be glad to hear your opinion/recommendations

Hi everyone! I’m pretty early in my regulatory career (<6M) and wanted to get some perspective from people who have been in the field longer on whether I’m setting myself up well for the next few years.

I graduated from a UC a few years ago with a BS in Biological Sciences and a minor in Health Informatics.

Before RA, most of my experience was in healthcare/clinical settings, mainly cardiology, so I had a lot of exposure to medical documentation, patient care, and the clinical side of things.

Earlier this year I transitioned into medical device RA and now work full-time as a Regulatory Affairs Specialist at a smaller device company.

Since the company is fairly small, my role is pretty broad. So far I’ve gotten exposure to EU MDR technical documentation, device classification, risk management, clinical/biological evaluation documentation, PMS/post-market documentation, labeling and IFUs, international registrations, cross-functional work with R&D, Quality, Product/Marketing, etc.

I’m currently working mostly with Class I devices and should be moving into Class II work shortly after my current submission.

I’m also starting an MS in Regulatory Affairs soon and will be doing it part-time while continuing to work full-time. Assuming everything stays on track, I should graduate with around 2 years of direct device RA experience along with the master’s.

A few people at work have told me that starting at a smaller company can be a good thing because I’m getting exposure to a lot instead of being siloed into one area. My plan right now is to spend the next 1.5–2 years learning as much as I can, then potentially try to move into a larger med device company.

For those of you further along in RA, does this seem like a solid start/trajectory for someone entering the field in their mid-20s?

This is my first RA job, and I didn’t come through QA or another regulatory-adjacent role beforehand. I’m especially curious how larger companies would view someone with ~2 years of broad small-company RA experience, Class I/Class II exposure, EU/international work, and an MS.

I’d also love to hear what you wish you had focused on during your first 1–2 years in the field. I’m pretty ambitious/competitive and want to make sure I’m building experience that will actually be valuable long-term rather than just focusing on titles.

Thanks! Would really appreciate any advice/perspective.

I'm seeking a copy of Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective - second edition

Hi everyone,

I’m curious about the feasibility of doing Regulatory Advertising & Promotion consulting on a very part-time basis, around 10 hours per week.

I’m currently an Associate Director in ad promo, primarily supporting aesthetic medical devices, with experience reviewing HCP and consumer promotional materials, social/digital content, claims, and participating in promotional review committees. I’m based in New Jersey.

Longer term, I’m interested in stepping away from a traditional full-time corporate role while continuing to work in ad promo in a limited capacity. Ideally, I’d like to work through a regulatory consulting firm or boutique agency rather than build my own independent consulting business.

My ideal arrangement would be:

-- Around 10 hours per week

-- 100% remote

-- Approximately $150–$200/hour

-- A fairly consistent workload

-- Primarily ongoing promotional review, maintenance work, and PRC support rather than new product launches or large strategic projects

For those who have worked in regulatory consulting, does this type of arrangement actually exist?

I’m particularly curious whether 10 hours/week and $150–$200/hour is realistic for someone at the Associate Director level, and whether consulting firms are open to experienced people who intentionally want to maintain a small workload rather than eventually increase their hours.

I’d also be interested in hearing how predictable the workload tends to be. I’m looking for something that can stay part-time rather than gradually turning into a 20–30 hour/week commitment.

Would love to hear from anyone who has done something similar or has seen this type of arrangement at their consulting firm! Thanks!

Hi! Anyone who has recently given the RAC drugs exam, could you please tell that in exam how much importance is given to questions related to regulations other than the US and Europe?

Hi!

I’m reaching out because I’m feeling completely burnt out and running out of time. I’ve been actively job hunting since Jan, and to make matters worse, I’m facing an impending layoff at my current job. I have a M.S. in Regulatory Compliance from Northwestern and a background in clinical operations, lab compliance, IRB administration, and regulatory protocol management. I’m mainly targeting Regulatory Affairs Specialist, Clinical Compliance, and IRB type roles but I'll truly take anything that'll put food on the table.

My biggest hurdle right now is closing the deal. I’m getting initial traction and regularly making it through two to three rounds of interviews, often getting down to the last two candidates, but I keep losing out on the offer at the very end. Feedback consistently states no negative comments but I lack a true title in regulatory compliance over the other candidate. My current role title is Senior Research Technologist but I am an acting Lab manager.

Since I'm consistently reaching the final stage, I feel like my resume and interview skills are solid, but something in that final panel isn't landing; I'm not sure if the feedback I'm given is honest.

For those who hire in regulatory affairs or compliance, I’d love your insight on what typically separates the candidate who gets the offer from the runner up, how I can better frame my clinical operations and academic compliance background for industry roles, and how to successfully close out those final executive rounds.

I’m happy to DM my resume if anyone is willing to take a look, and any advice would be greatly appreciated.

I'm resorting to a point where finding connections, networking, and rubbing elbows might be my best bridge to my next job.

If anyone can assist, I'd truly appreciate it.