FDA jobs in California

Alameda, California

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Today

IT SOX and GxP Analyst Alameda, CA (Onsite - no remote/hybrid) 6 Months Contract + Likely Extensions Job Description: Create the product vision, customer persona identification, product framework for IT s compliance practices including the scopes of SOX and GxPOur client is a public biopharmaceutical company that is regulated by different governmental agencies. It is important that IT operates in a manner that is consistent, accurate, and high quality so that they stay in compliance with GxP and

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Contract

$75 - $80

Portfolio Strategy Consultant

Sunnyvale, California

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5d ago

About Apexon: Apexon is a digital-first technology services firm specializing in accelerating business transformation and delivering human-centric digital experiences. We have been meeting customers wherever they are in the digital lifecycle and helping them outperform their competition through speed and innovation.Apexon brings together distinct core competencies in AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering and UX, and our deep expertise

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Full-time, Third Party

$120,000 - $140,000

Sr JD Edwards Developer

Remote

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5d ago

Sr. JD Edwards (JDE) Developer / Remote / Contract About our Customer and Role: Our premium customer, a global Fortune 500 company & a leader in the Food Services industry is looking for a Sr JD Edwards Developer for designing, developing, implementing, and supporting custom solutions within the JD Edwards (JDE) EnterpriseOne environment. Responsibilities: Design & Development Develop, enhance, and maintain custom applications, modules, and interfaces within JD Edwards EnterpriseOne.Support & M

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Contract

Depends on Experience

Commercialization & Validation Engineer

Remote or Hybrid

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Today

The CSA Validation SME is a key stakeholder within the ELC CSA Center of Excellence (COE). This role ensures the integrity of CSA projects with a strong focus on risk assessment, compliance, and regulatory adherence. Acting as a subject matter expert (SME), the CSA Validation SME serves as a bridge between COE leadership, protocol authors, and testers. The SME will ensure projects meet regulatory, data integrity, and organizational (R&D/GSC/IT) policies while maintaining best practices in valida

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Contract

$70 - $75 per hour

*Sr. JD Edwards Developer* W2 Role

Remote

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Today

Kellton Tech is a full-service software development company, offering end-to-end IT solutions, strategic technology consulting and product development services in Web, SMAC (Social, Mobile, Analytics, Cloud), ERP-BPM, and IoT space Our methodology of inventing infinite possibilities with technology helps us develop best in-class and cost effective solutions for our clients. Currently Kellton Tech is looking for talented resources for one of our listed client. Below are the position details Job

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Contract, Third Party

Depends on Experience

(100% REMOTE) Regulatory Affairs Reviewer Promotional Materials- 15 hours a week

Remote

•

Today

Degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.5 years experience in Regulatory Affairs advertising & promotion (ad promo) review or equivalent compliance function with overall RA experience of 10+ years.Strong knowledge of global and regional regulations governing promotional materials (e.g., FDA, EMA, IFPMA, local codes).Excellent attention to detail and ability to balance business needs with regulatory compliance.Strong communication skills to influence and guide cro

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Part-time

$80 - $100

Remote-Sr Business Analyst with Lifesciences client - CRM experience

Remote

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Today

Location: - Remote work but client would prefer candidates from New Jersey.Candidates should be authorized to work in the United States. Educational Qualifications: - Engineering Degree BE/ME/BTech/MTech/BSc/MSc.Technical certification in multiple technologies is desirable. The Senior Business Analyst Pharmaceutical is a pivotal client-facing role responsible for driving business transformation initiatives within leading pharmaceutical companies. This position requires deep expertise in FDA reg

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Third Party, Contract

Depends on Experience

Full Stack Engineer

Remote

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7d ago

Full Stack Engineer - Remote (EST)Responsibilities Collaborate with your team to design, develop, test, deploy, and maintain secure, compliant SaaS solutions Build and enhance software features to address customer challenges and improve user experience Drive continuous improvement efforts and support CI/CD processes throughout the development lifecycle Promote and implement automation to streamline workflows, reduce manual effort, and ensure consistency Engage in all stages of product deve

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Full-time

$135000

Product Owner

Remote or Hybrid in Pittsburgh, Pennsylvania

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Today

Company Overview: Req ID: 339286 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Product Owner to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). REMOTEJob Description: About the Role We are seeking a highly motivated and experienced Product Owner to support projects within the Heal

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Contract

BASED ON EXPERIENCE

Salesforce & TrackWise Digital Solution Architect

Remote

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3d ago

Position: Salesforce & TrackWise Digital Solution ArchitectLocation: RemoteType: Contract / Full-time Job SummaryWe are seeking an experienced Salesforce & TrackWise Digital Solution Architect to lead the end-to-end design and implementation of scalable, compliant, and high-performance digital quality systems. The ideal candidate will bring strong expertise in solution architecture, system integration, and governance for regulated environments (Life Sciences / Pharma preferred). Key Responsibili

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Contract, Third Party

$100,000 - $160,000

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

R&D Quality Partner

Remote

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21d ago

Job Title: R&D Quality Partner Diagnostics & Combination ProductsJob Location: RemoteType: W2/C2CDuration: 6 months (extensions possible)Start Date: ASAP Summary (Short JD):Seeking an R&D Quality Business Partner with strong expertise in diagnostics, medical devices, and drug-device combination products. This role will define and implement an R&D-focused Quality Management System (QMS), ensure compliance with FDA, EMA, ISO 13485/14971, EU IVDR, and 21 CFR regulations, and act as a strategic part

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Contract, Third Party

$35 - $45

SAP WM/EWM Functional Consultant (Pharmaceutical Exp)

Foster City, California

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10d ago

Job Title: SAP WM/EWM Functional Consultant (Pharmaceutical Exp) Location: Foster City, Local candidates only (Onsite role) Job Summary: + years of hands-on SAP functional experience in one or more of the following modules: MM, PP, WM/EWM, SD, QM, APO, IBP, Ariba.Strong industry expertise in Pharmaceutical, Manufacturing, or Supply ChainExperience with SAP S/4HANA preferred (implementation, rollout, or migration projects).Knowledge of GxP / GMP / FDA 21 CFR Part 11 compliance is a plus.

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Contract

Depends on Experience

Biostatistician/SAS

Remote

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20d ago

Position: Biostatistician -Open Position-HI Type: contract Duration: 12 months Location: Hawai Responsibilities. Write/review SAP and clinical trial protocol; develop and validate complex statistical models and SAS programs for analysis, management & reporting of clinical data. Perform statistical analysis, create and verify clinical trial reports and TLGs to support FDA submission. Req.: Master's degree/equiv. in Biostatistics, Statistics, Public Health or related. Proficiency in clinical dat

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Contract

Depends on Experience

Sr Engineer Process

California

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Today

Job Description Dar seguimiento a problemas de calidad relacin con Almacn y Produccion.Gestionar No Conformidades (NCs) y acciones correctivas/preventivas (CAPA).Coordinar liberacin de material y producto en almacn bajo estndares regulatorios.Liderar y soportar auditoras internas, externas y de clientes.Implementar y dar seguimiento a indicadores de calidad en procesos de almacn y distribucin.Colaborar con equipos multifuncionales (produccin, logstica, compras, proveedores).Ingeniera Industrial

Full-time

Human Factors Engineer

Thousand Oaks, California

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Today

Submit at a reasonable market rate Fully Remote - Any Time Zone Preferred: Local to Thousand Oaks, CA Ideal Candidate: 7-10 years of practical human factors experience in medical devices or combination products. Hands-on implementation experience required. Nice to Have: Experience with auto-injectors, human factors validation, and engagement with the FDA or global regulatory bodies. Job Description: Client is seeking a results-driven and experienced Human Factors / Usability Engineer (HF/UE)

Full-time

Veeva System Manager Veeva CRM

Hybrid in Sunnyvale, California

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Today

Veeva System Manager Sunnyvale, CA Onsite We are seeking a Veeva System Manager to lead the administration and optimization of the Vault Regulatory Suite, supporting global regulatory operations. The role includes system engineering responsibilities to align regulatory workflows with business strategy. Key Responsibilities: Manage Vault Regulatory modules (Submissions, Submissions Archive, Registrations). Ensure system compliance with global regulatory standards (FDA, EMA, etc.). Lead validat

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Full-time, Part-time, Third Party, Contract

Software QA Lead

Burlingame, California

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Today

Title: Software QA Lead - Medical Device Wearables Location: Burlingame, CA Pay: $60-$78/hr on W2 Contract: W2; 6 months with possibility of extensions Client: Fortune 500 CompanyMinimum Requirements: - Proven experience in software QA for regulated medical devices, specifically wearables. - Demonstrated expertise in mobile device applications and operating systems (iOS, Android, Windows). - Hands-on leadership experience in QA - Strong knowledge of ISO documentation standards and quality manag

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Full-time, Contract

BASED ON EXPERIENCE

Veeva System Manager Vault Regulatory Suite : Redwood City, CA

Redwood City, California

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Today

Hello, This is Deepak and I m a professional Recruiter with Vlink. VLink, founded in 2006, is a leading global provider of software engineering services with next-gen technologies and best-in-class talent. Our Headquarters are in the U.S, and we have offices in 7+ countries from North America-Europe to APAC, with expansion plans in the Middle East. With over 1,000 employees working globally, VLink has helped SMBs, and large enterprises achieve their business goals, and gained the trust of Fortun

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Contract

Depends on Experience

CSV Engineer

San Francisco, California

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Today

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Roles & Responsibilities: 10Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnol

Full-time

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FDA jobs in California, USA