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Beyond Regulation with Ceren: Insights, Career & MedTech

This newsletter will give you exactly what you need: Regulatory Insights, Career Tips and News in MedTech

Newsletter · By Dr. Ceren Karacay-Steinwender · English · Official site

Indexed issues, last 90 days
6
Latest publication
Sep 29, 2026
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Earliest in this view
Jul 7, 2026

Latest issues

  1. Issue · Sep 29, 2026

    #19: What Regulatory Affairs Really Runs On: Soft Skills (opens the original)

    Excerpt · Positive tone

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    This week, I want to continue with the soft skills topic. I explain how you can build and improve the soft skills needed to be successful in regulatory affairs. To be honest, this is not limited to the regulatory affairs profession. If you are currently working in adjacent departments such as quality control, quality assurance, or research and development, you can also apply these tips in your daily work.Enjoy the read!Leave a comment<a cla

  2. Issue · Sep 22, 2026

    Issue 18: You Don’t Wait Until VP to Influence People (opens the original)

    Excerpt · Neutral tone

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    I read a LinkedIn post from Conner Harman the other day, and it made me think.Do we only need to influence our colleagues when we are a VP or Head of

  3. Issue · Sep 8, 2026

    Issue 17: Same Title, Different Career: How to Read Pharma RA Roles (opens the original)

    Excerpt · Positive tone

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    This week, as promised, I continue expanding on the role of regulatory affairs in the pharmaceutical industry.To this day, I still love reading job descriptions. In the MedTech and pharmaceutical industries, two positions with the same title can sometimes feel like two completely different worlds. You can also see this difference when talking to regulatory affairs professionals and hearing about their day-to-day challenges, whether on coffee chats via LinkedIn or in person.In this issue, I expla

  4. Issue · Aug 3, 2026

    Issue 16: Same Title, Different Career: How to Read MedTech RA Roles (opens the original)

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    When you are looking at Regulatory Affairs jobs in MedTech, it is easy to assume that the title tells you what the job will be.You open two job postings. Both say “Regulatory Affairs Specialist.” Both are in MedTech. You assume the responsibilities, learning opportunities, and career trajectory will be similar.Wrong.One role might involve building technical documentation for a startup preparing its first CE marking. Another might focus entirely on post-market surveillance for a portfolio of esta

  5. Issue · Jul 21, 2026

    Issue 15: Where Does Regulatory Affairs End and Quality Assurance Begin? (opens the original)

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    If you work in MedTech, especially in a small or mid-sized company, you may have noticed something early on:Regulatory Affairs and Quality Assurance are often not clearly separated.You might be reviewing/writing sections of a technical documentation in the morning, supporting a deviation in the afternoon, and preparing for a notified body audit in between.At some point, it becomes hard to say where RA ends and QA begins.And in many SMEs, there is no clean boundary.This is not a mistake in struct

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