Heng & Hurst in Sydney is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy, submissions and compliance for MedTech SaMD portfolios. You will drive FDA and EU MDR pathways, collaborate with Quality, R&D; and Commercial teams, and oversee lifecycle management to bring innovative products to market.
The role offers hybrid working and the prospect to shape regulatory strategies across global markets, with direct reporting to the Head of Scientific Affairs.
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📌 Senior Regulatory Lead - Medtech Samd (Fda/Eu Mdr) (New South Wales)
🏢 Heng & Hurst
📍 New South Wales
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