regulatory-compliance jobs in San Diego

Director-level role leading clinical data management across multiple development programs at a therapeutic company. Responsible for overseeing data management CROs and vendors, ensuring data quality and regulatory compliance, managing the clinical data lifecycle (database build, data review, reconciliation, lock), and leading cross-functional teams.…See more Requires 10+ years of clinical data management experience, deep knowledge of FDA/EMA/ICH-GCP requirements, CDISC standards, EDC systems, and demonstrated ability to manage complex global trials.

Sr. Manager overseeing a data engineering team with responsibility for hiring, coaching, and performance management while remaining hands-on with architecture, design reviews, and technical decisions.…See more The role requires designing and operating production data pipelines and lakehouse platforms using AWS (S3, Glue, Athena, Lambda) and Snowflake, with hands-on proficiency in SQL and Python. Responsibilities include establishing data governance, compliance, security controls, CI/CD practices, and collaborating across engineering, analytics, product, and clinical teams to translate requirements into platform capabilities. The manager must balance delivery priorities, technical debt reduction, operational excellence, and emerging-technology evaluation while driving outcomes that affect broader business objectives.

Quality Analyst III serves as a Subject Matter Expert in Quality Management for healthcare programs (Medicaid and Fee-for-Service), establishing enterprise quality standards, governance frameworks, and SOPs. The role involves leading complex Root Cause Analysis investigations, overseeing quality activities across multiple implementations, and providing expert consultation to cross-functional teams on compliance and process improvement.…See more Responsibilities include evaluating regulatory requirements, championing continuous improvement initiatives, developing training materials, and acting as an escalation point for complex quality issues. The position requires 5+ years of experience with a BS/BA, proficiency in Microsoft Office (Word, Excel, Access, Project) and SQL, and strong analytical and communication skills.

Lead system-level design, integration, and validation of AI/GPU and database infrastructure platforms spanning compute, storage, networking, power, and thermal domains. Drive datacenter power architecture, thermal strategies, platform manufacturability, and cross-functional root-cause analysis across hardware, firmware, and systems engineering.…See more Develop validation tools in Python, Bash, or C, and influence platform architecture through technical insight on emerging infrastructure technologies. This is a broad systems engineering role requiring strong judgment operating across multiple engineering disciplines in enterprise and hyperscale environments.

Lead engineering across customer-facing and back-office platforms for a federally chartered bank, setting quality standards, performance benchmarks, and delivery practices for 300+ engineers across four organizational units. Own the shift from gate-based to continuous, AI-augmented quality practices; partner with architecture, DevOps, security, and product leadership to embed engineering strategy into roadmap decisions; and represent technical delivery health and capability investment needs to the CFO and board.…See more Requires 10+ years leading development/QA/business-analysis teams, hands-on fluency in modern architecture (microservices, API-first, Redis, CI/CD), direct experience with financial infrastructure (banking cores, settlement, blockchain), and a track record of rescuing major projects, building delivery operating models at scale, and deploying autonomous or semi-autonomous AI agents in workflows.

Senior Manager leading R&D strategy for digital health and AI/ML solutions in neuropsychiatry at a major pharmaceutical company. The role spans developing and validating digital endpoints, patient stratification approaches, and clinical trial optimization using advanced statistical modeling, multimodal data integration (digital phenotyping, speech/language analytics, imaging, biomarkers, omics), and longitudinal analysis.…See more Requires 6+ years in pharma/biotech analytics with demonstrated expertise in clinical development, digital health technologies, biostatistics, and machine learning; PhD or MD in a quantitative or clinical field preferred. Reports to senior leadership, partnering cross-functionally with clinical operations, regulatory affairs, and external collaborators to advance digital health standards and support regulatory qualification of novel endpoints.

As a Systems Architect, you will design and architect safety-critical flight systems for autonomous aircraft, defining novel control functions, decomposing aircraft and system architectures, and allocating functionality across vehicle, pilot, and support systems. You will perform trade studies, collaborate with safety and systems analysts to meet regulatory requirements, derive and validate requirements and interfaces, and support development through certification.…See more The role requires 7+ years of experience designing and integrating complex aerospace systems, a strong systems engineering background, and the ability to work independently and cross-functionally in a dynamic startup environment.

Sr. Systems Engineer I will translate complex technical findings into actionable recommendations for cross-functional teams (Quality, Manufacturing, Service Engineering, R&D, Regulatory, Leadership) in a medical device environment.…See more The role requires 4+ years of industrial systems engineering or product development experience, with strong preference for domain expertise in flow cytometry, cell analysis, signal processing, embedded systems, electronics, software, fluidics, optics, or assay reagents. Key responsibilities include executing system-level characterization, integration, and test procedures. A Bachelor's degree in engineering or related discipline is required; Master's or PhD preferred.

Senior Systems Engineer responsible for translating complex technical findings into actionable recommendations across Quality, Manufacturing, Service Engineering, R&D, Regulatory, and Leadership teams. Requires a bachelor's degree in engineering and 4+ years of industrial experience in systems engineering, product development, or sustaining roles.…See more Strongly preferred experience in flow cytometry or cell analysis domains (signal processing, embedded systems, electronics, software, fluidics, optics, assay reagents). Will execute system-level characterization, integration, and test procedures.

Design, develop, and test secure software using C++, Java, C#, or similar languages, creating novel cybersecurity technology components to defend against cyber exploits and attacks. Responsibilities include developing kernel and user-level software with security-first principles, conducting vulnerability assessments, implementing CI/CD and DevSecOps processes, and using Infrastructure as Code tools like Ansible and Terraform to deploy and configure systems.…See more Perform code reviews, validate security controls (STIGs, CMMC), participate in Risk Management Framework processes, and document software for accreditation. Partner with multidisciplinary teams and government sponsors to integrate custom and third-party components across complex systems.

As Assistant Vice President and Chief Information Security Officer, you will lead cybersecurity strategy and enterprise information security for a major integrated health system. You'll oversee a team of security analysts, engineers, and architects, manage 24/7 security operations centers, and collaborate with executive leadership to develop comprehensive security strategy aligned with organizational goals.…See more The role requires ten years of leadership/management experience with at least five in information security, plus expertise in healthcare security regulations, governance, risk management, and regulatory compliance.

The QA Engineer will define and implement quality assurance solutions for complex composite components in aerospace, defense, and space markets. Responsibilities include reviewing build manuals and engineering documentation for compliance with customer and regulatory standards, investigating material and production problems through root cause analysis, managing build manual revisions, leading Material Review Board (MRB) dispositions, and developing test solutions.…See more The role requires a Bachelor's degree in Engineering plus 3+ years of relevant QA experience, strong problem-solving skills, and expertise with AS9100 documentation and ERP systems.

The EDI Administrator supports Electronic Data Interchange compliance and reporting across multiple jurisdictions and lines of business. Primary responsibilities include collecting and analyzing claims, financial, and operational data; monitoring regulatory updates; reconciling FROI/SROI diaries and Medicare Section 111 reporting; identifying and resolving data discrepancies; and managing daily inbound/outbound EDI data flows.…See more The role partners with Claims, Compliance, IT, and regulatory agencies to ensure data quality, timeliness, and compliance with federal and state requirements, while identifying process improvements and supporting training initiatives.

As Senior Staff Quality Engineer at Dexcom, you will drive quality compliance and inspection readiness across products, processes, and systems in a medical device environment. You'll lead complex investigations, implement corrective and preventive actions, mentor engineers, and ensure adherence to FDA 21 CFR 820 and ISO 13485 requirements.…See more The role requires hands-on expertise in QMS frameworks, design control, regulatory inspections, and the ability to influence stakeholders across engineering, operations, and global sites to maintain continuous audit readiness.

Senior Manager leading systems engineering for complex Point-of-Care diagnostic instruments, overseeing hardware, software, consumable, and assay integration. Responsible for system architecture, cross-functional integration with external partners, regulatory compliance (ISO 13485, IEC 62366, IEC 60601, ISO 14971), and risk analysis.…See more Will mentor junior engineers, drive technical decision-making across R&D, Quality, Manufacturing, and Regulatory teams, and manage the full product lifecycle from concept through commercial launch in a regulated environment.

Senior Director of Engineering role leading cross-functional teams of engineers, systems integration scientists, and instrument software developers at a scientific instrumentation company. Responsibilities include developing engineering strategy aligned with business goals, overseeing product development from concept to commercialization, managing instrument control software integration with hardware, and ensuring compliance with quality and regulatory standards.…See more Requires 8+ years in engineering leadership and 12+ years total engineering experience, preferably in biotechnology or scientific instrumentation, with proven ability to manage complex projects through full lifecycle.

Principal Solution Architect driving technical and strategic leadership of LPL Financial's ClientWorks advisor platform. Architect cloud-native, scalable solutions spanning account opening, client management, trading, reporting, and design systems while ensuring security, compliance, and seamless third-party integration.…See more Lead cross-functional teams in modern architecture practices, DevSecOps, and CI/CD automation; mentor development teams and evangelize architectural standards across hybrid enterprise environments.

This role manages a cybersecurity program for clinical medical technology (diagnostic imaging and therapeutic radiation equipment) at a healthcare organization. The manager will lead staff, oversee regulatory compliance, conduct risk assessments and incident response, ensure HIPAA and Joint Commission adherence, and collaborate with clinical teams on technology security and reliability.…See more The position requires 3+ years of management experience, 5+ years in related healthcare technology work, and a bachelor's degree, with responsibility for budget, purchasing, and business operations.

Staff Technical Program Manager leading early-stage technology development projects within Dexcom's Innovation Ventures & Sensor Technology group. Oversees complex, cross-functional projects from concept through productization, managing project schedules, regulatory compliance, and technology risks while coordinating internal and external stakeholders.…See more Requires strong technical background in biomedical engineering, chemistry, or materials science with medical device development experience, particularly in sensor and algorithm development.

The HTM Cybersecurity Program Manager leads cybersecurity and clinical technology programs at a healthcare system, managing a team responsible for diagnostic imaging and therapeutic equipment maintenance, regulatory compliance, and incident response. The role requires directing staff performance, managing budgets and procurement, and ensuring HIPAA and Joint Commission compliance while mentoring technical teams.…See more Key responsibilities include risk assessment, cybersecurity strategy implementation, audit readiness, and collaboration with clinical teams to resolve technology issues affecting patient care. The ideal candidate brings 3+ years of management experience, 5+ years in healthcare technology operations, and deep knowledge of healthcare regulatory frameworks.

Senior Software QA Engineer supporting Dexcom's Postmarket Investigations team to assess real-world product performance, investigate software and device issues, and drive continuous improvement. You will collaborate across R&D, Quality, Regulatory Affairs, and Clinical teams to conduct root-cause analyses, perform risk assessments (including hazard analysis, DFMEA, PFMEA), and translate postmarket insights into product enhancements.…See more The role requires deep technical understanding of software architecture, structured problem-solving, statistical analysis, and the ability to communicate findings to both technical and non-technical stakeholders while ensuring regulatory compliance and patient safety.

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections.…See more The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.