Senior Director of Regulatory Affairs - Medical Devices

Job Description

Job Description

Salary : $230 - $280k + 25%

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Reporting to the SVP of Clinical and Regulatory, the Senior Director of Regulatory Affairs will support the strategic direction and lead the day-to-day execution of global regulatory activities. This role will be responsible for preparing high-quality regulatory submissions, supporting interactions with the FDA and other international regulatory bodies, and ensuring compliance with global requirements related to market authorizations, post-market surveillance, and regulatory reporting.

At Anteris, youll be part of a high-caliber team advancing a transformative therapy for aortic stenosis. We value accountability, objectivity, respect, teamwork, integrity, and courage, and were united by a shared purpose : improving patient lives through disruptive innovation. Were building something remarkableand were just getting started.

Key Responsibilities

• Create and execute global regulatory strategy for all Anteris products in alignment with business goals.
• Serve as a strategic advisor to the executive team on the regulatory implications of product and process changes.
• Develop and lead a high-performing global Regulatory Affairs team that supports company objectives across product lifecycles.
• Oversee department budget planning and resource allocation to ensure alignment with regulatory and business priorities.
• Ensure Regulatory Affairs participation on cross-functional project teams supporting new product development and product modifications.
• Lead timely renewals of global licenses, certificates, and product registrations.
• Provide guidance on the application of external standards across all projects.
• Maintain complete, audit-ready regulatory documentation and manage global submission packages.
• Direct regulatory activities related to field corrective actions and ensure appropriate product re-submissions and ongoing approvals.
• Support Quality Assurance in maintaining ISO / CE Mark certifications and related regulatory audits.
• Monitor evolving global regulatory requirements and assess their impact on Anteris products and systems.
• Conduct regulatory assessments for reportability and submit FDA MDRs and international vigilance reports as needed for tissue-based products.
• Review Engineering Change Requests (ECRs) for global regulatory impact.
• Lead or participate in regulatory review of promotional materials.
• Author, review, and approve internal procedures related to regulatory affairs operations and compliance.

Skills, Knowledge, Experience & Qualifications

What We Offer :

Health and Wellness Offerings

Note : We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and / or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. Wehave a clear vision : to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization.Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.