Senior Regulatory Lead - MedTech SaMD (FDA/EU MDR) (City of Sydney)

Senior Regulatory Lead - MedTech SaMD (FDA/EU MDR) (City of Sydney)

17 Aug
|
Heng & Hurst
|
City of Sydney

17 Aug

Heng & Hurst

City of Sydney

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 creative products to market.

The role offers hybrid working and the opportunity 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) (City of Sydney)
🏢 Heng & Hurst
📍 City of Sydney

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