171 articles for regulatory affairs professionals in pharma, biotech and medical devices: career guidance, role profiles, hiring trends and policy explainers. Updated Oct 10, 2026.
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FDA's OTC hearing aid rule created a distinct regulatory niche blending device discipline with usability fluency. Who's hiring, and how to position yourself.
FDA's cybersecurity expectations for connected devices are creating new regulatory affairs work at the intersection of security, quality, and submissions.
A practical explainer on how the EU AI Act layers onto MDR, IVDR, and pharma regulation, and what it means for the day-to-day work of regulatory affairs teams.
FDA's Predetermined Change Control Plan lets AI-enabled devices update without a new submission each time. Here's what that shifts in regulatory affairs work.
How ongoing MDR and IVDR enforcement in the EU is changing what medical device regulatory affairs employers are hiring for, and where the demand sits.
FDA's Quality Management System Regulation replaced the QSR in February 2026. What the harmonization with ISO 13485 means for regulatory and quality careers.
