Job Description

Job Description

Job Description

Senior Director of Regulatory Affairs - Medical Devices

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, you'll be part of a high-caliber team advancing a transformative therapy for aortic stenosis. We value accountability, objectivity, respect, teamwork, integrity, and courage, and we're united by a shared purpose: improving patient lives through disruptive innovation. We're building something remarkable—and we're 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

• Bachelor's degree in a technical field required; advanced degree preferred.
• 15+ years of experience in the medical device industry, ideally with exposure to structural heart technologies.
• At least 7 years of experience leading a Regulatory Affairs team.
• Hands-on leadership of regulatory submissions for Class III/PMA devices, including FDA (IDE, PMA) and EU (MDR, CA, CE Mark) pathways.
• Experience working with Notified Bodies through CE submissions and post-market requirements.
• Strong knowledge of global regulatory standards and quality systems, including ISO 13485, GMP, GCP, GLP, QSR, and MDR.
• Exceptional communication skills with the ability to craft clear, concise regulatory documents and collaborate across functions and levels.
• Proven project management skills, with a track record of driving robust submissions and compliance initiatives.
• Innovative, solution-oriented mindset with a strong focus on regulatory rigor and business alignment.
• Demonstrated leadership that fosters cross-functional collaboration, champions innovation, and drives accountability.
• A disciplined, strategic approach to risk management and regulatory compliance.
• RAC certification preferred.

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