Anteris Technologies

The Principal Regulatory Affairs Specialist will lead and execute European regulatory strategies for Class III cardiovascular devices, ensuring compliance with MDR (EU) 2017/745. This role involves managing technical documentation, coordinating with Notified Bodies, and providing regulatory guidance for clinical investigations and product lifecycle management.

The Clinical Specialist will provide procedural and clinical trial case support, including valve preparation and implantation, while ensuring compliance with clinical protocols. They will also identify educational opportunities for heart team members and contribute to trial enrolment and site-level metrics.

Perform detailed review and analysis of cardiac CT scans to support patient eligibility and procedural planning for global TAVR clinical studies. Collaborate with multidisciplinary teams and physicians to ensure consistent imaging assessments and protocol compliance across international sites.

Lead the end-to-end screening process for a global pivotal trial, ensuring accurate pre-procedure assessments and eligibility decisions. Collaborate with cardiologists and field teams to prioritize participants and ensure protocol compliance.

Support clinical research, physician engagement, and global regulatory strategies to advance breakthrough cardiac therapies. Manage the development and commercialization of biomimetic TAVR valves and anti-calcification technologies.