r/regulatoryaffairs

Could you please provide your opinion on the operations of two companies involved in the production of an excipient intended for marketing as a medical device? The period is between 2015 and 2018 in Europe.

Company A is the medical device manufacturer company with its own ISO13485 certification and CE.

Company B is the actual manufacturer and supplier of the main chemical molecule (the excipient).

The two companies signed the production contract and quality agreement in the third quarter of 2015.

Company B is not a GMP company and only holds ISO9001:2008 certification. Company B was audited at the end of 2014. 15 non-conformities were found, which were closed in December 2015. In the meantime, however, several batches were produced and delivered to Company A. The rules were supposed to be changed in March 2016 with the introduction of risk assessment (please confirm this). However, the two companies continued to operate until mid-2017 without evidence of having taken corrective actions. In late 2017, some supplies were contaminated and the supplies were interrupted. The two companies agreed to rework to resolve the problem and restart supplies. At the end of 2017, Company A issued a Quality Summary Report declaring Supplier B suitable for the production of the molecule, based on the 2014 audit and the 2015 QA, without making any mention of the defective supplies.

Question is if the process followed presents irregularities

Hi everyone! I'm a B.Pharm graduate currently learning more about clinical research and regulatory affairs. I'd love to hear from professionals in the field.

If you could give one piece of advice to someone just starting out, what would it be?

Thanks in advance for sharing your experience!

I’m trying to get a job in RA field but have no experience.
Can you please recommend some online education programs where you can get a certificate? At least something to start with.

Hello everyone,
I’m looking to transition into the regulatory affairs field, specifically within the pharmaceutical or medical device industry. I have a Bachelor’s degree in Chemical Engineering from Canada and recently completed a one-year Regulatory Affairs program. Despite my efforts, I’ve been struggling to break into the field.
I would greatly appreciate any advice, guidance, networking opportunities, or support from anyone who has successfully made a similar transition or works in the industry. Thank you in advance for your help!

Whether you work in medical devices, IVDs, pharma, or biotech...

What's one mistake or misconception you had when you first started in Regulatory Affairs or Quality?

Some examples:

• Misunderstanding FDA requirements
• Thinking ISO 13485 was "just documentation"
• Confusing verification vs. validation
• Writing ineffective CAPAs
• Underestimating risk management
• Missing the importance of design controls
• Something else entirely

What happened, and what lesson did you take away from it?

I always find real-world experiences far more valuable than textbook examples, and I'm sure others new to the field would too.

Hello,

Hopefully this is a good place to ask this but is there any availability of part time work as a regulatory affairs specialist in Med Device/IVDs at early/mid level and if so where do I look for it?

I’ve been looking at contract/consulting jobs for about a month on general job searches (e.g. LinkedIn) and everything I see is full time. I am thinking I’ll submit open applications to consulting agencies describing I am looking for part time (20-30 hrs a week) as well but I’m just wondering if there is another niche market I am missing.

For background:

I am currently within a full-time regulatory affairs position but due to some life situations I need to go part time. I don’t want to quit my current job but it seems that my company wouldn’t be open to me working part time long-term when I discussed it with my manager, so essentially I’ll get fired/have to leave if I request part time long term.

Hi everyone,

I'm researching promotional review workflows in pharma and trying to better understand how teams prepare for Medical, Legal, and Regulatory (MLR) review.

I'm curious:

• How are claims typically identified today?
• How do teams verify supporting evidence?
• How is label alignment assessed?
• What parts of the process are the most time-consuming or frustrating?

I'm not selling anything — just trying to learn how different organizations approach these workflows.

Would love to hear how your teams handle this today.

Hi everyone - for those of you who’ve worked at companies that take summer undergraduate/graduate interns in regulatory affairs, what kind of tasks and projects have you found to be appropriate to assign interns that would help them gain skills in the field and be helpful to the team? All suggestions and ideas welcome, thanks!

Hi everyone,

I’ve recently become really interested in a career in Regulatory Affairs, but I’m not sure how to make the transition.

I have a Bachelor’s degree in Biomedical Sciences, but after graduating I ended up in sales. I’ve spent the last couple of years working as an SDR/BDR in healthcare and IT, so my experience has not been really anything directly related to regulatory work.
I’m trying to figure out the best path to break into the field.

A few questions I have:
Is it realistic to get an entry-level Regulatory Affairs job with my background?
What types of positions should I be applying for?
Are there any certifications or courses that would actually help, or are they mostly unnecessary?

I’m interested in any field in pharma, biotech, med device, etc. Really anything related to this area.

I’d love to hear from anyone who transitioned into Regulatory Affairs from a non-traditional background or anyone involved in hiring, or have any connections who would be good to speak to. Any advice would be greatly appreciated!

Thanks!

Hey all!

I’m currently working in R&D and have been thinking about transitioning into Regulatory Affairs. I do not have an RA background, but I’d love to hear from anyone who has made a similar switch or works in the field.

What would be the best way to start preparing for this transition? Are there any specific courses, certifications? Also, what skills are most valued in Regulatory Affairs for someone coming from a technical R&D background?

Hey everyone,

I’m working on a lightweight tool to automate the worst parts of the midnight eCTD submission crunch, and I need your brutally honest feedback.

With agency automation getting tighter, spending hours manually hunting down formatting typos right before a deadline feels insane. I'm building a secure, private "Pre-Flight Compliance Guard" that lets you drag-and-drop your draft to auto-check three specific bottlenecks in 60 seconds:

• Text vs. Table Typos: Automatically flags metric/unit mismatches (e.g., text says 10 mg/mL but the table says 100 mg/mL).
• eCTD Path Sanitizer: Catches and renames paths that break the 200-character limit or contain illegal gateway characters.
• Hyperlink Validator: Crawls the compiled PDF to find broken internal links, cross-references, or missing leaf nodes.

Note: It runs on a zero-data-retention structure to protect proprietary IP.

If you work in RA or RegOps, would a micro-tool like this actually save your sanity during a crunch week, or am I totally missing the mark? What's your biggest manual headache?

Regulatory Affairs professionals—I'm curious about your experiences with 510(k) submisisons for new devices.

What's the single biggest pain point in your 510(k) process today?

Examples could be:

• Finding and organizing supporting documentation
• Predicate device comparisons
• Writing or reviewing sections
• Cross-functional coordination
• FDA feedback cycles
• Version control
• Something else entirely

If you had a magic wand and could eliminate one part of the process, what would it be?

Hi, I am working in reg affairs field with drugs in EU, but I want independently learn how to submit med device etc. I know that in this field expirience is everything so do you have advice how to catch up with med devices (EU) so I can tell that I know to work with them?

The FDA 510(k) process often looks straightforward on paper, but in practice, it's usually the preparation—not the submission—that takes the most time.

One area that seems to cause the biggest challenges is documentation. Technical files, test reports, labeling, software information, and risk management documents all need to align. Even small inconsistencies can lead to additional questions during the review.

Another key step is selecting the right predicate device. A strong comparison helps build the foundation for demonstrating substantial equivalence, while a poor choice can make the submission much more complicated.

I've also noticed that cross-functional coordination is often underestimated. Regulatory, R&D, QA, and testing teams all contribute to the submission, so keeping documents organized and up to date is just as important as writing the application itself.

In my opinion, manufacturers who start regulatory planning early and maintain clear documentation throughout development are usually in a much stronger position when it's time to prepare a 510(k).

While regulatory requirements continue to evolve, careful planning and well-structured documentation remain essential for a successful 510(k) submission. I'd be interested to hear what challenges others have encountered during the process.

Hey everyone,

As the title says, I’ve spent over 10 years working in a wet lab environment. Unfortunately, I got caught in the layoffs almost a year ago. As we all know, the job market right now is brutal, and after a year of searching, I’m realizing it’s time to pivot out of the bench life.

I’m currently looking into two potential paths and would love some realistic feedback:

1. Clinical Trial Associate (CTA) roles
2. Regulatory Affairs (RA) roles

For anyone who has successfully made this jump from the bench, what did your transition look like? Would you rate the difficulty as Easy, Medium, or Hard?

A few specific questions I have:

• The Experience Gap: How did you convince hiring managers that your wet lab experience translates to clinical data or regulatory compliance?
• Certifications: Did you need to get a certificate (like RAC for regulatory or a CCRA for clinical) just to get your foot in the door, or did you learn on the job?
• The Market: Given how tough the market is right now, is one of these fields a bit more "forgiving" to newcomers than the other?

I'd appreciate any advice, resume tips, or harsh realities you can throw my way. Thanks in advance!

I'm curious about the learning curve in Regulatory Affairs and Quality.

For those working with medical devices, IVDs, pharma, or biotech:

What regulatory topic was hardest to understand when you started?

FDA requirements?

ISO 13485?

Risk management?

EUMDR?

CAPA?

Or was it something else entirely?

Hi everyone,

I’m looking for opportunities in Regulatory Affairs (RA) or Quality Assurance (QA) in the Greater Phoenix Area and would appreciate any advice, referrals, or connections.

I have a Bachelor of Pharmacy and a Master of Pharmacy (Pharmaceutics) from India, along with 2 years of experience in the pharmaceutical industry in production and formulation development. I recently graduated with MS in Regulatory Science at Arizona State University.

I’m interested in entry-level to early-career positions such as:
Regulatory Affairs Associate/Specialist, Quality Assurance Associate/Specialist, Quality Systems Associate, Compliance Associate, Document Control Specialist, Regulatory Operations Associate

If your company is hiring, or if you know of any organizations in the Phoenix area that are open to candidates with pharmaceutical and regulatory backgrounds, I would be grateful for any leads or referrals.

Thank you for your time and support!

Hi guys,
I am planning to take RAC devices exam -Summer 2026 and I am concerned if I would be eligible.
I emailed RAPS that my experience is Freelance with a Masters Degree in Biomedical Science. They said you are eligible but I am worried if they say otherwise when I register for the exam.
My experience is mixed. LIke i have documentation for QMS, Risk management, Clinical evaluation, biocompatibility domains for different clients compliant with US FDA and EU MDR.

What should I do?