For device makers, the biggest shift is already in force. FDA's Quality Management System Regulation took effect on February 2, 2026. It amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, which makes risk management an explicit requirement. On the same date FDA stopped using its Quality System Inspection Technique (QSIT) and moved device inspections to an updated compliance program, 7382.850. Candidates who prepared sites for QSIT inspections should be able to explain what has changed for them.
In Europe, Regulation (EU) 2023/607 extended the MDR transition. Class III and class IIb implantable devices have until 2027 and most other legacy devices until 2028, provided the manufacturer met conditions such as applying to a notified body by May 26, 2024. The European Commission then proposed a targeted revision of the MDR and IVDR on December 16, 2025, which would, among other changes, remove the five-year maximum certificate validity. The European Parliament and Council must agree it before it applies, so check its status before planning around it.
At the agency itself, HHS announced in March 2025 a restructuring that would cut about 3,500 FDA positions, and said drug, device and food reviewers and inspectors would not be affected. Ask experienced candidates what they have seen in their own agency interactions since then.