How to Start a Career in Regulatory Affairs: A Step-by-Step Guide for Beginners (with Free Online Study Plan)

By Viviane Santos – Pharmacist & MSc Candidate in Medical Technology – Regulatory Affairs



If you’re curious about Regulatory Affairs (RA) but don’t have industry experience, this guide is for you. Below, I share a practical roadmap and a free 6-week online study plan to help you take your first steps into this exciting and strategic field.


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Step-by-Step: Starting a Career in Regulatory Affairs


1. Understand what Regulatory Affairs is

RA professionals ensure that medical products (drugs, devices, cosmetics, etc.) meet all regulatory requirements to be marketed safely and legally.


2. Learn the key regulations

Start with the basics:

• EU MDR 2017/745 (Medical Devices – Europe)

• FDA 21 CFR Part 820 (Quality Systems – USA)

• ISO 13485 (QMS for Medical Devices)

• ANVISA RDCs (Brazil)


3. Build technical English skills

Most regulatory documentation and communication is in English. Use glossaries from the FDA or EMA to get familiar.


4. Explore real regulatory documents

Examples: Technical files, Instructions for Use (IFUs), conformity certificates, Risk Management Plans (ISO 14971).


5. Follow the free 6-week online study plan below


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Free Online Study Plan – 6 Weeks for Beginners


Week 1: Introduction to Regulatory Affairs

• Read: What is Regulatory Affairs? – TOPRA

• Watch: FDA Basics


Week 2: EU MDR 2017/745 Fundamentals

• Read: EU MDR Official Summary

• Watch: EU MDR Explained – YouTube


Week 3: FDA 21 CFR + ISO 13485

• Read: FDA QSR Overview

• Free course: Coursera: ISO 13485 – Overview


Week 4: Risk Management & ISO 14971

• Read: Intro to ISO 14971 – Risk for Medical Devices

• Watch: [Risk Management Basics – YouTube or Khan Academy]


Week 5: Regulatory Documentation & Technical Files

• Read: IFU templates, Technical File Checklist (MEDDEV 2.7/1 Rev 4)

• Watch: “How to build a technical file” – YouTube


Week 6: Soft Skills + LinkedIn Optimization

• Read: How to write a strong professional summary

• Task: Post a short article about what you’ve learned so far + connect with professionals in RA


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Bonus Tips: How to Stand Out Without Experience

• Attend free webinars from RAPS, DIA Global, EMA, and ANVISA

• Share insights from your learning journey on LinkedIn

• Add regulatory keywords to your LinkedIn and CV

• Practice interpreting regulatory texts in English

• Stay updated: Subscribe to EMA, FDA, and ANVISA alerts


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Regulatory Affairs is a growing, global field — and there’s space for new voices. Start learning today. Knowledge is your most powerful tool.

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