Principal Regulatory Affairs Specialist

Who We Are PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact. Where You Fit PathAI is seeking an experienced Principal Regulatory Affairs Specialist to play a key role in supporting regulatory strategies and ensuring the success of our diagnostic products in the global market. This role involves preparing global product submissions, including but not limited to PMA, 510(k), UKCA, and IVDR filings. As a key contributor to the regulatory team, you will work cross-functionally with internal stakeholders, providing critical regulatory guidance throughout the product development lifecycle. The ideal candidate will have a strong foundation in regulatory affairs, particularly in IVDR submissions, and be adept at managing detailed regulatory processes in a fast-paced, high-growth environment. What You'll Do Regulatory Submissions and Documentation: Prepare and manage regulatory submissions, particularly for FDA 510(k), PMA, and EMA IVDR filings, ensuring technical accuracy and compliance. Organize technical files, design dossiers, and regulatory documentation for diagnostic products, including AI-driven and IVD devices. File pre-submission requests and respond to inquiries from global regulatory bodies. Author/write regulatory documents in support of our submission process. Oversee regulatory operations, including the management of regulatory documentation, tracking of submissions, reporting, data analysis, and the development of dashboards or metrics to monitor and optimize regulatory processes. Serve as a key point of contact with regulatory agencies, supporting regulatory submissions, pre-submissions, and addressing questions or additional information requests. Compliance and Product Development Support: Provide regulatory expertise and guidance to cross-functional teams (engineering, clinical, quality) during product development, ensuring compliance with relevant standards (FDA QSR, ISO 13485, IVDR, ISO 14971). Partner with the Quality team to maintain and improve the quality management system (QMS), ensure alignment with current regulatory standards and best practices for diagnostics and SaMD (Software as a Medical Device). Stay informed of regulatory updates, advising internal teams on how changes in guidelines may affect regulatory strategies and submissions. Regulatory Strategy and Risk Management: Contribute to regulatory strategy development by collaborating with leadership to identify the most efficient pathways for product approval. Conduct regulatory risk assessments and provide input on product classifications, design controls, and validation testing. Monitor evolving global regulatory landscapes, especially related to AI in diagnostics, and advise teams on strategic adjustments as needed. Cross-Functional Collaboration: Work collaboratively across various teams, offering regulatory support throughout the product life cycle, from concept to market approval. Assist in preparing for and supporting audits and regulatory inspections. What You Bring Experience: 5+ years of experience in regulatory affairs, with a focus on diagnostic devices and proven experience with FDA and EMA Dx submissions (510(k), PMA, IVDR). Expertise in regulatory submissions for in vitro diagnostic devices (IVD), particularly in AI-driven technologies, pathology, and SaMD (Software as a Medical Device). Demonstrated hands-on experience in leading regulatory filings and bringing products to market globally, with an emphasis on the US and EU markets. Experience with US Class III and EU IVDR Class C (high-risk) medical device development. Knowledge of global regulatory standards, including FDA QSR, ISO 13485, IVDR, and ISO 14971. Educational Background: Bachelor's degree in engineering, physical, or life sciences (Advanced degree preferred). Skills & Competencies: Excellent organizational skills, with the ability to manage multiple projects, prioritize tasks, and work independently to drive submissions forward. Ability to manage details effectively while contributing to broader regulatory strategies. Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams. We Want To Hear From You At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for. PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications "” that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way. #J-18808-Ljbffr

Created: 2024-11-05