Dawn is our international RA/QA mastermind—strategizing from her base in Switzerland and helping clients confidently navigate (and occasionally decode) the differences between EU and US medtech markets.
Dawn joins the leanRAQA team with a Doctorate in Materials Science and Engineering and more than 20 years of hands-on regulatory and quality leadership—from early design through market access, post-market, and everything in between. She has driven global strategies for 510(k) and PMA submissions, breakthrough device pathways, EU MDR transitions, and the implementation of ISO 13485/MDSAP quality management systems. As a certified ISO 13485 Lead Auditor, she’s known for de-risking submissions and building inspection-ready QMS frameworks that strike the perfect balance between efficiency and excellence.
Her device experience spans the alphabet and beyond: complex drug–device combination products, orthopedic implants, cardiovascular devices, insulin delivery systems, and SaMD.
Fun Fact: Dawn is an enthusiastic urban gardener with more than 80 plants thriving on her rooftop terrace. When she’s not cultivating her sky-high jungle, you’ll likely find her by the ocean or exploring a new corner of the world.
