fda-regulations jobs in San Diego

Senior Automation Engineer supporting the development, maintenance, and operation of complex custom automation systems in a biotech environment. Responsibilities include understanding system requirements, developing scripted protocols, supporting system integration across hardware and software, troubleshooting failures, and ensuring compliance with FDA regulations and GxP principles.…See more The role requires proficiency in C#, experience with robotics, motion control, machine vision, and strong problem-solving skills to maintain system uptime in a regulated biotech setting.

Lead Clinical Data Manager responsible for directing data management activities across the full lifecycle of one or more clinical studies, from database setup through lock and close-out. The role includes managing CRO and EDC vendor performance, authoring core data management documentation (DMP, DRP, guidelines), ensuring compliance with FDA regulations, ICH-GCP, and CDISC standards (CDASH, SDTM), and representing Data Management on cross-functional teams.…See more Requires 7–10+ years of clinical data management experience with demonstrated expertise in EDC systems (Medidata Rave preferred), vendor oversight, FDA/ICH/HIPAA regulations, and oncology knowledge including RECIST/RANO criteria.

Senior embedded software engineer responsible for designing, developing, and integrating embedded C/C++ software for next-generation intravascular ultrasound (IVUS) medical devices. The role requires 7+ years of embedded systems experience, strong hardware/software integration skills, expertise with microcontrollers, DSP, FPGA, and data acquisition systems.…See more Responsibilities include ultrasound signal processing, FPGA-to-console interfaces, diagnostics/test software development, and cross-functional collaboration with FPGA, electronics, systems, and manufacturing teams.

Senior Automation Engineer responsible for developing, maintaining, and operating complex custom automation systems in a biotech stem-cell therapy environment. The role requires designing scripted protocols, integrating hardware and software components, troubleshooting system failures, and ensuring compliance with FDA regulations and GxP principles.…See more Requires 5+ years in hardware design, automation, or biotech; proficiency in C#; and hands-on experience with robotics, motion control, sensors, and machine vision systems.

Senior IT Program Manager supporting the execution of moderately complex IT initiatives within a pharmaceutical company's Value Management Office. Leads or supports cross-functional technology projects from initiation through stabilization, with responsibility for scope, schedule, budget, quality, compliance, and business outcomes.…See more Requires 4+ years of IT experience in a pharma/biotech environment with FDA regulation exposure and hands-on knowledge of validated applications, web technologies, databases, and Microsoft application stack (SQL Server, Oracle, Java, web standards).

This role involves designing, developing, and implementing Körber PAS-X Manufacturing Execution Systems (MES) for life sciences manufacturing environments. Responsibilities include configuring Electronic Batch Records (EBRs), integrating MES with ERP and control systems, and ensuring GxP compliance and FDA/GMP adherence.…See more The consultant will document MES configurations, validate solutions, and work directly with clients to define strategic needs and deliver value-added solutions. Minimum 2 years of hands-on PAS-X MES experience in highly automated life sciences manufacturing is required.

The Senior Automation Engineer will develop, maintain, and troubleshoot complex custom automation systems for biotech applications, with a focus on hardware–software integration and regulatory compliance. Responsibilities include writing operational protocols, performing system integration, conducting verification and validation testing, and collaborating across cross-functional teams.…See more The role requires a strong foundation in automation engineering principles, C# proficiency, hands-on experience with robotics, motion control, sensors, and machine vision, plus familiarity with FDA regulations (21 CFR Parts 11, 210, 211, 820) and GxP principles.

Lead verification and validation of cloud-connected medical device systems, designing and executing comprehensive test plans while developing automated test frameworks in Python. Test Microsoft Azure cloud applications, APIs, and infrastructure alongside embedded medical device software in regulated environments.…See more Mentor other test engineers, support CI/CD pipelines, and perform root cause analysis on defects. Requires 10+ years in software testing/QA, deep Azure and Python expertise, hands-on embedded medical device testing experience, and SDLC/V&V process knowledge.

Support Computer System Validation (CSV) activities for GxP-regulated pharmaceutical and medical device systems, including validation planning, test execution, documentation, and compliance verification against FDA regulations and 21 CFR Part 11. Execute validation test scripts, document results and deviations, conduct impact and risk assessments, and collaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements.…See more Maintain validation records, support change control and CAPA activities, and identify compliance gaps in regulated computerized environments.

Staff Quality Engineer for a medical device manufacturer responsible for owning and continuously improving the Quality Management System across the full product lifecycle. The role involves coordinating QMS processes and documentation, leading design control programs, managing change control reviews, directing CAPA activities, handling complaints and supplier qualification, and leading internal audit programs.…See more Requires 8–10+ years of medical device quality experience, 3+ years in quality system auditing, and strong expertise in ISO quality systems and FDA-regulated device standards.

Principal Systems Engineer leading full product development lifecycle for a Class II Medical Device, defining system architecture and engineering strategy across electrical, firmware, software, and manufacturing domains. Owns multidisciplinary systems end-to-end, establishing development processes (CI/CD, automated testing, version control), leading embedded hardware and firmware architectures, and ensuring FDA compliance and Design Controls adherence.…See more Serves as primary technical authority coordinating internal teams and external partners, conducting design/architecture reviews, supporting manufacturing scale-up, and mentoring cross-functional engineers. Requires 12+ years of multidisciplinary product development with demonstrated systems engineering expertise, regulated-industry experience, and technical leadership without direct authority.

Lead the development and release of a next-generation iOS application for an FDA-cleared insulin pump, building new patient-facing features while maintaining a legacy app and contributing to shared core components. Own end-to-end delivery with emphasis on medical device compliance (FDA, ISO), HIPAA security, and accessibility standards.…See more Write clean, well-tested Swift and SwiftUI code leveraging modern concurrency patterns, work with CoreBluetooth and CoreData, and collaborate across engineering, design, and product teams.

Senior Software Engineer at Globus Medical responsible for full lifecycle management of medical device software products, from research and design through testing and delivery. The role requires strong full-stack development skills in .NET/C# backend and JavaScript/TypeScript frontend, with proficiency in Azure DevOps, Git, and web technologies including HTML5, CSS/SCSS, LitElement, and WebComponents.…See more Must follow FDA regulations, ISO 13485, and IEC 62304 standards in a regulated medical device environment, and perform some DevOps functions. Requires 8+ years of experience (or equivalent with advanced degree) in object-oriented design, Agile/TDD methodologies, and cross-functional collaboration with product management and engineering teams.

Sr. Principal Specialist will oversee clinical database programming operations, including review/cleaning programs, validation procedures, database migrations, SAS dataset creation, and vendor management within a pharmaceutical environment.…See more The role requires hands-on technical expertise in Medidata Rave, SAS, and SQL alongside strategic leadership of cross-functional teams and oversight of regulatory compliance, inspection readiness, and system implementations. Responsibilities include proactive risk mitigation, evaluation and adoption of new technologies, and acting as a technical liaison across Clinical Data Management, Clinical Operations, Regulatory, and IT. The ideal candidate combines 8+ years of clinical database programming experience (or equivalent with advanced degree) with expert knowledge of CDISC standards, GCP regulations, and end-to-end drug development processes.

This Software Design QA Engineer role focuses on ensuring software development conformance to FDA, IEC 62304, and ISO 13485 standards in a medical device company. The engineer will lead design assurance activities including risk management (SHA, design FMEA), design control reviews, configuration management, and post-market compliance support.…See more The role requires expertise in medical device software development lifecycle processes, regulatory frameworks, and cross-functional collaboration with engineering, test, and regulatory teams.

Senior Automation Engineer supporting development, maintenance, and operation of complex custom automation systems in a biotech environment. Responsibilities include understanding system requirements, developing scripted protocols, integrating hardware and software components, troubleshooting failures, and ensuring compliance with FDA regulations and GxP principles.…See more Requires 5+ years in hardware design, automation, or biotech, with proficiency in C#, robotics, motion control, machine vision, and electronic systems integration.

Senior Automation Engineer at a biotech firm developing autologous stem-cell therapies. Responsible for developing, maintaining, and troubleshooting complex custom automation systems, including scripted protocols, hardware-software integration, and verification/validation testing.…See more Requires 5+ years in hardware design, automation, or biotech, with strong C# software integration skills, robotics and motion control expertise, and knowledge of FDA regulations (21 CFR 11, 210, 211, 820) and GxP principles.

The Senior Automation Engineer will develop, maintain, and troubleshoot complex custom automation systems in a biotech setting, working with hardware (robotics, motion platforms, sensors, machine vision) and software (C# codebases). Responsibilities include creating operational protocols, supporting system integration, developing verification and validation plans, and ensuring compliance with FDA regulations (21 CFR Parts 11, 210, 211, 820) and GxP principles.…See more The role requires 5+ years in hardware design, automation, or biotechnology, with strong problem-solving skills and the ability to collaborate across cross-functional teams.