EU rules for medicines, devices and diagnostics are being rewritten at the same time. Our deepest regulatory work is on the manufacturing, CMC and device side; for clinical and pharmacovigilance searches, specialist research support extends the reach, with Russell leading the search.
The EU pharma package sets 8 years of regulatory data protection plus 1 year of market protection as the baseline, with extensions possible. Formal adoption was still pending; EMA expects the new rules to apply from 2028.12
For hiring: Regulatory strategy leads will re-plan dossiers and exclusivity periods for every product in development.
EU joint clinical assessments apply to new cancer medicines and advanced therapies, extending to orphan medicines from January 2028 and all new medicines from January 2030.3
For hiring: Regulatory and market access now have to build one EU-level evidence package together.
For eligible legacy devices that meet the transition conditions, class C diagnostics needed a signed notified-body agreement by 26 September 2026 and must fully comply by 31 December 2028; class D by 31 December 2027 and class B by 31 December 2029.4
For hiring: Diagnostics companies need regulatory capacity now, and interim cover is often the fastest route.
For eligible legacy devices that meet the transition conditions, class III and implantable class IIb devices have until 31 December 2027 and all other classes until 31 December 2028, with exceptions set out in the regulation.4
For hiring: Medtech companies still need people who can take devices through recertification with a notified body.
All clinical trials in the EU, including those that started earlier, run under the Clinical Trials Regulation through the CTIS portal.5
For hiring: Clinical operations roles now ask for hands-on CTIS experience.
The European Medicines Agency is based in Amsterdam.6
For hiring: Amsterdam is the centre of EU regulatory work, and a strong draw for regulatory professionals.
Regulatory titles hide very different jobs. A Head of Regulatory with EU and FDA submission experience, a device specialist who knows notified bodies, and a CMC regulatory lead are three separate candidate pools, and budgets are often set for the cheapest of them.
Many companies also try to combine quality and regulatory in one head. For a scale-up adding manufacturing, that means hiring someone strong at half the job. In one of the stories below we advised a scale-up to split it: a Head of Quality now, the regulatory appointment later, once the submissions calendar was clear.
For MDR/IVDR projects and submissions that cannot wait for a permanent hire.
Search for Heads of Regulatory and RA Directors, starting with an honest check of profile against budget.
Advice on whether quality and regulatory should be one role or two, before the search starts.
Head of Quality and Regulatory split into a Head of Quality now and a regulatory appointment later.
Read the full story →Permanent RA lead left mid-IVDR programme; freelance RA specialist placed to carry it, structured around the Wet DBA.
Read the full story →A thirty-minute call with Russell, no pitch deck. You'll leave with a view on whether it's a search, an interim, or neither.