Beyond Regulation with Ceren: Insights, Career & MedTech
Dr. Ceren Karacay-SteinwenderThis newsletter will give you exactly what you need: Regulatory Insights, Career Tips and News in MedTech
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 11 | Founded | a year ago | Last Issue | 15 days ago |
| Active | |||||
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beyondtheregulation.substack.comLatest Issues
Issue 11: How to Choose? Small company vs Corporate Setting
Regulatory affairs moves fast. Guidelines get updated, deadlines shift, and new frameworks come into force before most courses have a chance to cover them.
That is exactly why this newsletter covers important regulatory news. The goal is t...
Issue 10: Regulatory Affairs: The Art of Stakeholder Debate
The recent IVDR and MDR proposals have confirmed what we already know: regulatory affairs is dynamic and multifaceted. Manufacturers, the EU Commission, Notified Bodies, and MedTech Europe all claim to prioritize patient safety, yet their p...
Issue 9: Why I Sit Through the Whole Audit?
Last week I sat through a two-and-a-half-day Notified Body surveillance audit. All sessions, start to finish.
My role was to cover Regulatory Affairs topics: Regulatory Intelligence, Post-Market Surveillance, and Vigilance. But I stayed fo...
Issue 8: Why Nobody Teaches You How to Get a Job in Regulatory Affairs?
Over the last few weeks, I ran a couple of quizzes here. And many of you answered. Thank you. Genuinely!
Your responses told me something useful: a lot of people are navigating the job market, preparing for interviews, or trying to transla...
Issue 7: Why do I suggest free courses?
When people try to break into Regulatory Affairs, the problem is rarely motivation.
It is the big picture.
There is a lot of information available. Regulations, guidance documents, videos, posts, discussions. But without context, it ofte...
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The writers behind this newsletter.
Hi, I’m Ceren. I climbed the ladder in academia only to jump off—straight into the world of regulatory affairs. In this newsletter, I share what I’m learning and discovering along the way. Join me!
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