# issue regulatory (audio feeds) — RSS Amplifier Recent posts from the 1 feeds in the RSS Amplifier directory that cover issue regulatory. Page: Feed: --- ## [Issue 16: Same Title, Different Career: How to Read MedTech RA Roles](https://beyondtheregulation.substack.com/p/issue-16-same-title-different-career) _2026-08-03 · Beyond Regulation with Ceren: Insights, Career & MedTech_ The same Regulatory Affairs title can describe completely different careers. What the role actually looks like often depends on multiple factors. Read the details in this week´s edition. ## [Issue 15: Where Does Regulatory Affairs End and Quality Assurance Begin?](https://beyondtheregulation.substack.com/p/issue-15-where-does-regulatory-affairs) _2026-07-21 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Why are Regulatory Affairs and Quality Assurance often combined in MedTech SMEs and what does this mean for your career? This issue explores RAQA integration, a peanut allergen reagent recall involving false-negative risks, and the importance of robust manufacturing controls ## [Issue 14: How Regulatory Affairs Changed the Way I See Everyday Things?](https://beyondtheregulation.substack.com/p/issue-14-how-regulatory-affairs-changed) _2026-07-07 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Ever noticed how regulatory affairs changes the way you look at everyday things? This week's issue is about exactly that. ## [Issue 13: Free Resources to polish your technical knowledge](https://beyondtheregulation.substack.com/p/issue-13-what-are-you-doing-with) _2026-06-23 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Q4 is one of the quarters when companies hire the most. Are you preparing for it? ## [Issue 12: Change Control Approved: Switching to Summer](https://beyondtheregulation.substack.com/p/issue-12-change-control-approved) _2026-06-09 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Give me a beach, a cold drink, and absolutely no agenda. That is my summer. ## [Issue 11: How to Choose? Small company vs Corporate Setting](https://beyondtheregulation.substack.com/p/issue-11-why-staying-current-on-regulatory) _2026-05-26 · Beyond Regulation with Ceren: Insights, Career & MedTech_ This issue focuses on why staying updated with RA news matters for interviews and how to think about the “small company vs corporate” career choice. I also highlight an interesting LinkedIn post that shares a useful tip for reading job descriptions. ## [Issue 10: Regulatory Affairs: The Art of Stakeholder Debate](https://beyondtheregulation.substack.com/p/issue-10-regulatory-affairs-the-art) _2026-05-19 · Beyond Regulation with Ceren: Insights, Career & MedTech_ What each stakeholder prioritzes in MedTech, interesting recall and career transition to RA from other departments in MedTech ## [Issue 9: Why I Sit Through the Whole Audit?](https://beyondtheregulation.substack.com/p/issue-9-why-i-sit-through-the-whole) _2026-05-12 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Another audit with a Notified body, my takey from 2,5 days of audit and implementing regulation that will change the everyday life of RA and QA professionals. ## [Issue 8: Why Nobody Teaches You How to Get a Job in Regulatory Affairs?](https://beyondtheregulation.substack.com/p/issue-8-why-nobody-teaches-you-how) _2026-05-05 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ Explore why preparation is key to success, the use of ChatGP for interview prep, and signs of a fake QMS. ## [Issue 7: Why do I suggest free courses?](https://beyondtheregulation.substack.com/p/issue-7-why-do-i-suggest-free-courses) _2026-04-28 · Beyond Regulation with Ceren: Insights, Career & MedTech_ There is a lot of information available. Regulations, guidance documents, videos, posts, discussions. But without context, it often feels like pieces that don’t fully connect. ## [Sync Bookmarks Everywhere (Sponsored)](https://crawlproof.com/a/XxDrG2Vn6huc) _2026-04-28 · **Sponsored**_ Two-way sync keeps folders and toolbar intact across Chrome, Firefox, and Safari. ## [Issue 6: Why breaking into Regulatory Affairs is "that hard"?](https://beyondtheregulation.substack.com/p/issue-6-why-breaking-into-regulatory) _2026-04-21 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Everyone says breaking into Regulatory Affairs is “hard.” And honestly? They’re not wrong. ## [Issue 5: Why do I write about recalls?](https://beyondtheregulation.substack.com/p/issue-5-why-do-i-write-about-recalls) _2026-04-14 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ Vigilance requirements are rarely black and white. They depend on your product, how well you know it, your experience, and… context. ## [Issue 4: Why did I start this newsletter?](https://beyondtheregulation.substack.com/p/issue-4-why-did-i-start-this-newsletter) _2026-04-07 · Beyond Regulation with Ceren: Insights, Career & MedTech_ I am interested in many aspects of regulatory affairs. Not just one corner of it. And more importantly, I have always been interested in people and their careers. ## [Issue 3: I moved from pharma RA to MedTech RA. Here’s what surprised me the most.](https://beyondtheregulation.substack.com/p/issue-3-i-moved-from-pharma-ra-to) _2026-03-31 · Beyond Regulation with Ceren: Insights, Career & MedTech_ What moving from pharma RA to MedTech RA taught me ## [Issue 2: Why I am on a mission to help others in Regulatory Affairs!?](https://beyondtheregulation.substack.com/p/issue-2-why-i-am-on-a-mission-to) _2026-03-24 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ To this day, I’ve had one major and one minor career pivot. ## [Issue 1: Welcome to my world!](https://beyondtheregulation.substack.com/p/issue-1-welcome-to-my-world) _2026-03-17 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ You may know me from LinkedIn, or maybe this is your first time seeing my newsletter.