Teams at Noctrix Health

Administer the electronic Quality Management System, controlled document lifecycle, employee training records, quality records, supplier documentation, calibration records, and inspection-ready archives. Support change control, CAPA, audits, inspections, validation, nonconformances, complaints, and finished goods release. Maintain data integrity and compliance with FDA requirements, ISO 13485, and Good Documentation Practices while partnering cross-functionally to improve quality processes.

Lead the planning, execution, and oversight of medical device clinical studies from start-up through close-out. Manage clinical strategy, sponsor oversight, sites, CROs, vendors, budgets, timelines, data quality, risk mitigation, regulatory evidence, and inspection readiness. Collaborate across Regulatory Affairs, Quality, Product Development, and Clinical Research to support approvals, reimbursement, commercialization, and post-market evidence. Lead and develop Clinical Affairs personnel while improving processes, systems, KPIs, and operational execution.

Lead medical device regulatory activities across development, submissions, commercialization, registrations, and post-market compliance. Prepare and manage FDA 510(k) and international submissions, assess product and software changes, maintain regulatory records, oversee MDR and vigilance reporting, review promotional and labeling materials, support inspections, and coordinate cross-functional regulatory projects with internal teams, consultants, and authorities.