Principal Regulatory Affairs Specialist - Medical Devices

Anteris Tech•Maple Grove, MN

4d•$120 - $170

About The Position

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 Senior 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 remarkable—and 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.

Requirements

Bachelor’s degree in science or engineering required. Advanced degree is a plus.
Minimum of 5 years of experience in Regulatory Affairs; 8+ years’ experience preferred
Minimum of 5 years’ medical device industry experience including Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier, and HDE submissions.
Class III medical devices experience required; cardiovascular experience preferred. Experience with tissue heart valves is a plus.
Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully and professionally with all levels of personnel.
Strong interpersonal, analytical, writing, and organizational skills, including the ability to find creative regulatory solutions in “grey” areas.
Demonstrated ability in project management skills to plan, conduct and implement system assessments and robust submissions
RAC Certification preferred.

Nice To Haves

Experience with Global Regulatory Agencies (Notified Bodies, Competent Authorities, Health Canada, TGA) preferred.
Class III medical devices experience required; cardiovascular experience preferred. Experience with tissue heart valves is a plus.
RAC Certification preferred.

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