Lead and perform regulatory submission and approval activities for medical device products, primarily focusing on the FDA and North American markets. Coordinate with international regulators to ensure compliance with corporate standards and manage product field corrective actions.
Anteris Technologies
3 Remote Job Openings at Anteris Technologies
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.
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.
