Principal Regulatory Affairs Specialist Elucent MedicalPrincipal Regulatory Affairs SpecialistEden Prairie, MinnesotaThe Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post-market activities. Required: direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.