Job Description
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 cutting-edge 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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