Regulatory Affairs Consultant

Summary: This consultant will be responsible for preparing regulatory FDA submissions for our client's products including pre-submissions.

Responsibilities: Coordinate communication and information flow for premarket and post-market regulatory activities. Prepare responses to FDA inquiries and requirements and support regulatory documentation and submissions. Partner with R&D, Quality Assurance, Clinical Affairs, and other cross-functional teams to gather and integrate submission data. Identify and assess regulatory risks, support risk control measures, and develop mitigation strategies. Support Quality Management System (QMS) activities, including CAPA, customer complaints, and internal audits. Participate in internal/external audits and inspections, ensuring compliance with the QMS, ISO 13485, and other applicable regulations. Manage regulatory projects and information requests while supporting process improvements and implementation of regulatory tools.

Qualifications: Bachelor's degree in Life Sciences, Medical Technology or a related field required.5+ years of experience in regulatory affairs and 8 years of overall industry experience. Knowledge of US FDA 21 CFR 807 is a must. US FDA 21 CFR 803/806/820 knowledge is a plus. Experience with software and AI submissions to the FDA.