Regulatory affairs professionals often ask whether they can move between pharmaceuticals and medical devices. The answer is usually yes. Core skills such as writing clear submissions, managing agency questions and running a regulatory strategy carry across. What changes is the framework, the evidence a regulator expects, and the way products move through their lifecycle.
Different frameworks, same discipline
In pharmaceuticals, much of the work centres on applications built around clinical and CMC data and on lifecycle variations after approval. In medical devices and in vitro diagnostics, the starting point is classification. The device's risk class drives the route to market, whether that is a US premarket notification or approval, or conformity assessment under the EU MDR or IVDR with a notified body. Learning to classify a product and choose the right pathway is the first skill to build.
Design controls and the technical file
Device regulatory work is closely tied to design controls. Regulatory specialists in device companies regularly read and contribute to design history, risk management files built to ISO 14971, usability and verification evidence, and the technical documentation a notified body reviews. If you come from pharma, spend time understanding how design inputs, outputs, verification and validation link together, because that chain is what reviewers test.
Clinical evidence works differently
Device clinical evaluation can draw on literature, equivalence and post-market data as well as investigations, and diagnostics rely on performance evaluation. The reasoning is familiar to anyone who has argued benefit and risk for a drug, but the structure and terminology are different. Reading a few public summaries of safety and performance is a useful way to learn the style.
Post-market is continuous
Post-market surveillance, vigilance reporting, trend reporting and periodic safety updates are a major part of device regulatory life. Pharmacovigilance experience is valuable here, and many professionals find this the easiest bridge into devices.
How to position your experience
- Lead with transferable work: submissions, agency interactions, labeling, change assessment and inspection support.
- Show you have learned the device vocabulary: classification, essential requirements or general safety and performance requirements, technical documentation, notified bodies.
- Mention any exposure to quality systems such as ISO 13485, even if it was indirect.
- Be honest about gaps and explain how you are closing them, through training, reading or project work.
How we help
We recruit regulatory professionals for pharmaceutical, biotechnology, medical device and diagnostics companies, and we can tell you which employers are open to candidates crossing between sectors. See regulatory affairs roles or send us your resume.