Regulatory Affairs Specialist

About This Role

The Regulatory Affairs Specialist supports global regulatory submissions, registrations, and product lifecycle activities for OrganOx products, with a focus on regulatory information management and coordination across the Regulatory Affairs function. The role works closely with Regulatory Affairs team members responsible for software, hardware, disposable products, and labelling to support submission activities, maintain accurate regulatory records, and ensure alignment across product areas and markets. This position reports directly to the Director, Regulatory Affairs and works collaboratively with colleagues and cross-functional partners throughout the organization.

Responsibilities

• Support the preparation, compilation, review, and submission of regulatory filings for OrganOx products in the United States, European Union, Canada, Australia, and other markets
• Work collaboratively across the Regulatory Affairs function, including software, retained unit, disposable set, labelling, and regulatory systems, to coordinate regulatory deliverables and maintain alignment across product areas
• Support regulatory authority and Notified Body interactions associated with assigned submissions and regulatory activities
• Create, maintain, and periodically reconcile regulatory records to ensure accurate representation of product registrations, submissions, approvals, certificates, licenses, regulatory commitments, market status, and other regulatory information
• Support configuration, process improvements, reporting, and implementation of new functionality within Rimsys
• Maintain alignment between regulatory records, change-control activities, approved product configurations, and other applicable business systems
• Support maintenance of regulatory registrations, renewals, annual reports, and other recurring regulatory obligations
• Collaborate with Regulatory Affairs and cross-functional stakeholders to support assigned regulatory activities and ensure regulatory requirements and deliverables are appropriately communicated and completed
• Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies

Requirements

• Working knowledge of medical device regulatory requirements and FDA regulatory processes
• Ability to prepare clear and well-organized regulatory documentation and submissions
• Working knowledge of medical device regulatory requirements in one or more international markets such as the European Union, Canada, and Australia
• Experience with regulatory information management systems or similar data systems; Rimsys experience preferred
• Experience collaborating cross-functionally with Manufacturing, Quality, R&D, Clinical, Marketing, and other business functions
• Strong organizational skills and attention to detail, with an ability to manage multiple priorities