This newsletter will give you exactly what you need: Regulatory Insights, Career Tips and News in MedTech
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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.
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
Ever noticed how regulatory affairs changes the way you look at everyday things? This week's issue is about exactly that.
Q4 is one of the quarters when companies hire the most. Are you preparing for it?
Give me a beach, a cold drink, and absolutely no agenda. That is my summer.
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.
What each stakeholder prioritzes in MedTech, interesting recall and career transition to RA from other departments in 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.
Explore why preparation is key to success, the use of ChatGP for interview prep, and signs of a fake QMS.
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.
Everyone says breaking into Regulatory Affairs is “hard.” And honestly? They’re not wrong.
Vigilance requirements are rarely black and white. They depend on your product, how well you know it, your experience, and… context.
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.
What moving from pharma RA to MedTech RA taught me
To this day, I’ve had one major and one minor career pivot.
You may know me from LinkedIn, or maybe this is your first time seeing my newsletter.
