Regulatory Affairs Specialist - Medical Devices

Regulatory Affairs Specialist

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. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Specialist will lead and execute regulatory submission and approval activities for the company's medical device products, with a primary focus on U.S. FDA submissions. This role will also provide support for international regulatory submissions outside North America. The Specialist will coordinate with FDA and international regulatory bodies throughout the submission and review processes to ensure timely approvals and ongoing compliance with applicable regulations and corporate standards.

In addition, this role will support regulatory aspects of clinical studies. This position will contribute to a collaborative team environment with the unique opportunity to directly impact our mission, vision, and values as we take the company to the next level of success.

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 remarkableand we're just getting started.

This role may be filled at varying levels, e.g., Senior or Principal, depending on the candidate's previous experience.

Key Responsibilities

• Drive regulatory planning and execution to ensure alignment with business and functional goals and priorities
• Prepare and review FDA submissions and other regulatory documents including 510(k)s, PMAs, PMA Supplements, PMA Amendments, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications and periodic study reports, as assigned
• Actively engage as the Regulatory Affairs representative on project teams
• Serve as a liaison with the Regulatory Agencies globally by conducting negotiations with agency reviewers as needed
• Review and interpret regulatory requirements as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
• Document review and approval to assure regulatory compliance (manufacturing process and product, change order, promotional review)
• Ensure that regulatory requirements are fully understood, implemented and / or mitigated in new product, clinical, marketing, and other business processes
• Communicate regulatory strategies and project status to internal stakeholders (Clinical Affairs, R&D, Marketing, Quality, Manufacturing)
• Interact with and influence external regulatory agencies and trade associations
• Author, review, and / or approve internal operating procedures related to regulatory affairs
• Coordinate timely renewal of certificates, licenses, and global product registrations
• Support Quality Assurance in maintaining ISO / CE Mark certifications and related regulatory audits
• Participate in complaints process in assessing and reporting to appropriate agencies

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. We have 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.