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.
n
The role offers hybrid working and the chance to shape regulatory strategies across global markets, with direct reporting to the Head of Scientific Affairs.
#J-18808-Ljbffr
📌 Senior Regulatory Lead - MedTech SaMD (FDA/EU MDR) (New South Wales)
🏢 Heng & Hurst
📍 New South Wales
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.