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Job #03024

About our client Our client is a young venture-backed biotechnology company with several locations on the East Coast that focuses on the development and commercialization of devices for the orthopedic industry. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director of Regulatory Affairs East Coast, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure that all worldwide regulatory requirements are met 2) Manage US and outside US regulatory registrations, MDRs, vigilance reports and registrar change notifications 3) Oversee 510(k)s, technical files, design dossiers, IDEs, PMAs and PMA supplements 4) Prepare and direct documentation for submission to regulatory agencies around the world 5) Direct all major regulatory projects 6) Interact with other departments to ensure regulatory requirements are understood and completed in an effective and timely manner 7) Perform internal and external audits with other auditors in the company 8) Interface and source on regulatory policies for Quality Assurance and Quality Control 9) Promote regulatory awareness throughout the organization 10) Manage labeling, IFU and collateral marketing materials’ compliance 11) Establish regulatory policies and strategies in full compliance with all applicable regulatory requirements Requirements 1) BA/BS in Science, Engineering or Medical Technology (advanced degree preferred) 2) Minimum 10 years of experience in regulatory affairs 3) Experience in management, quality and regulatory affairs 4) Experience in working with regulatory agencies (e.g., FDA, competent authorities) and registrars/notified bodies 5) Expertise in orthopedic industry preferred 6) Knowledge of FDA, QSR, MDD and ISO 13485:2003 7) Excellent communication skills (written) 8) Team player