The Director of Clinical & Regulatory Affairs is a key leadership position leading the planning and execution of critical Clinical and Regulatory Affairs activities for the company’s current commercial product – Bladder EpiCheck, a non invasive test indicated for the detection and recurrence monitoring of bladder cancer and upper tract urinary cancer. This role provides overall program leadership and management, and ensures cross-functional alignment as well as effective collaboration with external partners.
• Overall responsibility for conducting Bladder EpiCheck regulated in vitro diagnostic (IVD) clinical trials in Europe and in the US, with and/or without company collaborators.
• Lead and manage cross-functional team(s) in the planning and execution of clinical trials in compliance with good clinical practices (GCP), department procedures and regulatory requirements.
• Oversee the preparation of all applicable documents required for the conduct of the study (i.e., Trial Master File (TMF), Clinical Protocols and Reports).
• Build and maintain clinical program timelines and drive clinical timelines in line with clinical and regulatory strategy and core team.
• Lead the development and implementation of Bladder EpiCheck regulatory strategies and processes (CE, IVDR, FDA) to gain and expand product approvals in US, EU and other markets; work with relevant regulatory consultants as may be required.
• Serve as regulatory affairs expert in company development programs by identifying, planning, driving, tracking and delivering on key regulatory milestones/objectives
• Interact with FDA, EU Notified Bodies and other global regulatory bodies and registration authorities as required to ensure timely, well thought, effective dialog and submissions
• Proactively partner with R&D, Product Development, Marketing, Quality, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on the market globally
• Lead the Company’s clinical and regulatory activities associated with Bladder EpiCheck collaborations with external partners.
• Support / advise regarding possible clinical studies performed by, or with research partners / KOLs
• At least 8 years of experience in medical device or IVD clinical and regulatory affairs, with progressive management experience managing trials and vendors
• M.Sc or higher degree in a scientific discipline
• Extensive experience managing clinical programs, CROs, budgets, and timelines, including hands on experience in the performance and execution of key clinical trial activities (writing study protocols, contracting and managing clinical sites, managing recruitment challenges, ensuring adequate data collection and recording, analyzing and reporting study data etc.)
• Strong knowledge of Notified Bodies, CE/IVDD/IVDR and FDA requirements, and regulations of IVD products
• Hands on experience in the performance and execution of key regulatory activities (writing regulatory applications, writing responses to regulatory agencies etc.)
• Demonstrated problem solving capabilities, along with strong organizational skills and a collaborative attitude
• Excellent written and verbal communication skills
• Ability and willingness to travel up to 20% of the time, as needed
• Fluent English