Heather Johnson (PhD, RAC) is a senior consultant with over 20 years’ regulatory expertise in drug-device combinations, borderline products and companion diagnostic devices. With a PhD in chemistry, her initial regulatory experience was with oral pharmaceutical products, followed by over 10 years leading global submissions for implantable, resorbable and drug-eluting orthopaedic devices with DePuy Synthes companies of Johnson & Johnson. Her career continued developing strategies for implementation of the EU Medical Devices Regulation across Johnson & Johnson devices companies. She then contracted for QIAGEN GmbH, to support clinical performance studies and marketing submissions for oncology companion diagnostic devices in US, EU, China and Japan. Heather now supports clients with US and EU regulatory strategies and submissions for drug-device combination products, novel devices, companion diagnostics and combined device and medicinal product clinical trials.
Events/Masterclasses Heather Johnson is currently speaking at
Pharma
Companion Diagnostics (CDx) - Navigating the Regulatory Challenges
11 – 12 June 2025
Vienna, Austria
The implementation of the EU In Vitro Diagnostic Device Regulation 2017/746 (IVDR) has introduced new processes for the authorization of performance studies and conformity assessment of companion diagnostic devices (CDx) in Europe.
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Heather Johnson (PhD, RAC) is a senior consultant with over 20 years’ regulatory expertise in drug-device combinations, borderline products and companion diagnostic devices. With a PhD in chemistry, her initial regulatory experience was with oral pharmaceutical products, followed by over 10 years leading global submissions for implantable, resorbable and drug-eluting orthopaedic devices with DePuy Synthes companies of Johnson & Johnson. Her career continued developing strategies for implementation of the EU Medical Devices Regulation across Johnson & Johnson devices companies. She then contracted for QIAGEN GmbH, to support clinical performance studies and marketing submissions for oncology companion diagnostic devices in US, EU, China and Japan. Heather now supports clients with US and EU regulatory strategies and submissions for drug-device combination products, novel devices, companion diagnostics and combined device and medicinal product clinical trials.
