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 opportunity to shape regulatory strategies across global markets, with direct reporting to the Head of Scientific Affairs.
Senior Regulatory Lead - MedTech SaMD (FDA/EU MDR) in Sydney employer: Heng & Hurst
Join a purpose-driven healthcare organisation in the heart of Sydney CBD, where your role as a Medical Affairs Associate will not only enhance your professional skills but also contribute to meaningful health outcomes. With a strong emphasis on employee growth and a collaborative work culture, you'll have the opportunity to engage with key opinion leaders and influence product strategies while ensuring compliance and scientific integrity. This dynamic environment fosters innovation and values your contributions, making it an excellent place for those seeking a rewarding career in consumer health.
