Director Quality Assurance Regulatory Affairs

Director of Quality & Regulatory Affairs - Medical Devices?? Location: North San Diego | ?? Full-time | ?? Medical Device IndustryWe are seeking a Director of Quality & Regulatory Affairs to provide strategic leadership and oversight of compliance, regulatory, and quality activities for our breakthrough medical technologies. This is a high-impact role responsible for ensuring patient safety, regulatory success, and operational excellence as we bring innovative devices to market.Compliance & Risk ManagementAct as Management Representative of the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR), and global standards for sterile implantable and electronic devices.Lead Risk Management activities per ISO 14971, guiding the Risk Management Team in assessing product changes and monitoring design/development activities for compliance with design controls.Manage internal audits, post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations.Regulatory AffairsDefine regulatory pathways for new products and product changes (e.g., Letter to File, 510(k) submissions).Coordinate with regulatory consulting partners to prepare and execute 510(k) submissions for Class II devicesMaintain oversight of labeling, documentation, and regulatory assessments throughout the product lifecycle.Design Verification & Validation (V&V)Review design documentation & support development of V&V protocols to confirm conformance to specifications, standards, and process controls using statistically valid methods.Oversee data collection and reporting for V&V results, software validation, hardware testing, and performance testing protocols.Quality Assurance & OperationsOversee management of Nonconforming Materials (NCMR), Corrective and Preventive Actions (CAPA), and supplier qualification metrics.Guide creation and implementation of inspection and test methods, improving manufacturing quality, product assembly, and inspection integrity.Contribute to building and maintaining the Design History File (DHF) and Device Master Record (DMR)Lead document control and change order management across the organization.QualificationsBachelor's degree in engineering, life sciences, or related field (advanced degree preferred).10+ years in the medical device industry, with at least 5 years in a leadership role.Deep knowledge of FDA/QSR, ISO 13485, ISO 14971 and related international standards.Experience leading 510(k) preparation and submissions for Class II devices.Technical proficiency in MS Office, Matlab, PLM systems (Agile), and application of statistical techniques.Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance.

Created: 2025-10-02