Anteris Technologies

Compliance

• Lead and execute regulatory submission and approval activities for the company’s medical device products, with a primary focus on U.S. FDA submissions.
• Provide support for international regulatory submissions outside North America.
• 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.
• Support regulatory aspects of clinical studies.
• Contribute to a collaborative team environment and impact company mission, vision, and values.
• 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.

Regulatory Affairs Specialist, Medical Devices