Jobs 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.

Supports clinical research and medical device development through Python tooling, clinical and physiological data analysis, signal processing, firmware and embedded systems testing, device characterization, and software, algorithm, and medical device verification and validation. The role contributes to clinical studies, machine learning evaluation, root cause investigations, technical documentation, and regulated design control activities while collaborating with Clinical, Engineering, Quality, Regulatory, and Product teams.

Designs and maintains full-stack software supporting patient-facing, clinical, and customer support applications. Owns backend data processing, RESTful APIs, integrations, storage architectures, and React web functionality while collaborating on Flutter mobile applications. Responsibilities include improving security controls, troubleshooting production systems, leading technical reviews, maintaining regulated development documentation, mentoring engineers, and partnering with product, clinical, quality, regulatory, and support teams.

Supports daily accounting operations across accounts payable, accounts receivable, general ledger maintenance, reconciliations, journal entries, and month-end close. Prepares invoices and payments, monitors collections, maintains audit-ready records, supports financial reporting, audits, tax preparation, and internal controls, and resolves accounting discrepancies. The role also partners cross-functionally and improves accounting systems, automation, and financial workflows in a growing medical device company.

Leads digital content, platform management, and growth marketing strategies across websites, advertising, social media, email, and partnerships. Owns campaign execution, performance optimization, analytics, lead generation, and full-funnel growth initiatives. Manages agencies and vendors while collaborating with marketing, sales, product, clinical, regulatory, and executive teams to strengthen brand visibility and conversion.

Leads Noctrix Health’s global marketing strategy, brand positioning, go-to-market execution, demand generation, digital and lifecycle marketing, communications, analytics, and customer acquisition across provider and consumer audiences. Builds and mentors the marketing organization, manages budgets and external partners, develops category leadership, and advises executive leadership on growth, market opportunities, and customer insights within regulated healthcare and medical-device markets.

Leads Quality Engineering activities across medical device new product development, sustaining changes, design controls, verification and validation, risk management, design transfer, and manufacturing implementation. Serves as a Design Control SME, reviews quality documentation, supports CAPA and nonconformance investigations, coordinates with suppliers and contract manufacturers, supports audits and inspections, and mentors cross-functional teams while ensuring FDA, ISO 13485, and ISO 14971 compliance.