Fda jobs in california

Micro Contamination Investigator/Documentation Consultant

San Jose, California

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Yesterday

Arthur Lawrence is looking for a Micro Contamination Investigator/Documentation consultant one our clients in San Jose, CA. Please find the job description below and send us your updated resume if interested: Must-Have Skills:3-5 years of experience in microbiology manufacturing, with knowledge of aseptic processing, environmental monitoring, and cleanroom classification. Strong understanding of FDA, EMA, and EU GMP Annex 1 regulatory requirements, with experience preparing deviation investiga

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Third Party, Contract

Depends on Experience

Technical Program Manager

Bell Gardens, California

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28d ago

Payrate: $90.00 - $100.00/hr. Responsibilities:Release Program Leadership:Manage deliverables to completion for Companys FDA approved Hearing Correction feature - software as medical device (SaMD) in accordance with Quality Management System (QMS) software release process end-to-end: define release scope, schedule, and milestones.Maintain a single source of truth for release status, dependencies, risks, and open items across all functions.Cross-Functional Coordination:Coordinate release activit

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Contract, Third Party

$90 - $100

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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9d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Third Party, Contract

$80 - $90

Validation Analyst

Hybrid in San Francisco, California

•

Yesterday

Role Overview Seeking an experienced Validation Analyst to support Roche's GIP program, focusing on validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The role will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness. Key Responsibilities Develop and execute Computer System Validation (CSV) deliverables, including validation plans, risk assessments, IQ/OQ/PQ protocols, and validation summary reports.

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Full-time

60 - 70

Engineering Project Manager - Medical Devices

Goleta, California

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Today

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better . We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insura

Full-time, Contract

From USD 92000.0 to 129500.0 per year

Validation Analyst

Hybrid in San Francisco, California

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Yesterday

Job Title: Validation AnalystProject: Medical Imaging & Algorithm Workbench Location: San Francisco, CA Work Model: Hybrid 4 Days Onsite Role OverviewWe are seeking an experienced Validation Analyst to support Roches GIP program, focusing on the validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The ideal candidate will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness while supporting software rele

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Contract, Third Party

70 - 80

Software Engineer (Systems) 4

Santa Clara, California

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Today

Description: Position Summary: As Staff Site Reliability Engineer Engineer, you will serve as a technical individual contributor responsible for supporting architecture, securing, and sustaining the production infrastructure supporting our regulated digital health and medical software platforms. You will ensure reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITRUST standards for healthcare data protection. You will lead initiatives i

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Contract, Third Party

$88 - $88

Regulatory Affairs Specialist Small Molecule

Remote

•

Yesterday

Job Title: Clinical Regulatory Affairs Specialist Small Molecule Location: Remote We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.Key Requirements:Strong experience in Clinical Regulatory AffairsHands-on experience with Veeva Vault TMF or similar.Experience with IND, CTA, and NDA submissionsKnowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirementsExperience supporting clinical

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Contract, Third Party

Depends on Experience

Bioinformatics Product Owner

Remote

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23d ago

Hello, We are seeking an experienced Product Owner to drive the development of a cutting-edge test designed to identify clinically actionable mutations in patients with solid tumors. This role is crucial in ensuring seamless coordination across software development, bioinformatics, clinical genomics, and regulatory teams to deliver high-quality, compliant, and innovative software solutions for precision oncology. Pay rate : $42 on W2 OR $48 on C2C Location : Remote Key Responsibilities: Define a

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Contract

40 - 45

Validation Engineer

Irvine, California

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14d ago

Job summary We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience with IQ/OQ/PQ, process andequipment validation, verification and validation (V&V), CAPA, root cause analysis,and process improvement. The candidate will collaborate with cross-functional teams and customers to ensure validation activities meet regulatory, quali

Full-time

Pharmacovigilance (PV) Specialist / Drug Safety Case Processing Specialist/Clinical Trial Consultant

Remote

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8d ago

Job Description: Responsible for processing and quality checking (QC) of clinical trial and post-marketing Individual Case Safety Reports (ICSRs). Key responsibilities include case intake, triage, data entry, MedDRA coding, narrative writing, follow-up queries, case reconciliation, and ensuring timely regulatory reporting in compliance with global pharmacovigilance regulations. Required Skills: Bachelors degree in Science or a healthcare-related field. 4+ years of experience in Pharmacovigilance

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Contract

Director - Food & Agri. Business Transformation

Remote

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16d ago

Director - Food & Agri. Business Transformation Mode - Remote (MST) Job Type: Full Time Experience Requirement: 15-20 years: Recent experience must be with a leading consulting firm serving the Food & Agribusiness sector. Preferred employers: Big 4 Consulting or equivalent.Across the overall career span, candidate must possess ~5 years of Industry domain experience in Food & Agribusiness. The ideal candidate should have deep, demonstrable expertise across one or more Food & Agri sub-sectors Ag

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Full-time

Depends on Experience

Computer System Validation Engineer

San Diego, California

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14d ago

Job Summary: We are seeking a motivated and detail-oriented Computer System Validation (CSV) Engineer with 1-2 years of experience to support validation and compliance activities within the Pharmaceutical and Medical Devic e industries. The ideal candidate will assist with the validation of computerized systems in regulated GxP environments and ensure systems comply with applicable regulatory and quality requirements. The candidate should have a strong understanding of validation principles, doc

Full-time

Staff Site Reliability Engineer Engineer - healthcare, medical device, or life sciences industries

Hybrid in Santa Clara, California

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Today

Position Summary:As Staff Site Reliability Engineer Engineer, you will serve as a technical individual contributor responsible for supporting architecture, securing, and sustaining the production infrastructure supporting our regulated digital health and medical software platforms. You will ensure reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITRUST standards for healthcare data protection. You will lead initiatives in incident response, d

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Contract

75 - 88

Site Reliability Engineer

Hybrid in Sunnyvale, California

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2d ago

Job Title: Site Reliability Engineer Location: Sunnyvale, CA - Hybrid (Onsite 3 days a week) Position Summary:As Staff Site Reliability Engineer Engineer, you will serve as a technical individual contributor responsible for supporting architecture, securing, and sustaining the production infrastructure supporting our regulated digital health and medical software platforms. You will ensure reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITR

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Contract

75 - 80

Manufacturing Engineering Manager

Irvine, California

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Today

Lead Manufacturing Excellence in a Growing, FDA-Regulated EnvironmentA well-established and innovative medical technology manufacturer is seeking a Manufacturing Engineering Manager to lead a high-performing engineering team responsible for manufacturing processes, production equipment, New Product Introduction (NPI), and continuous improvement initiatives. This is a hands-on leadership opportunity for an engineering professional who enjoys developing people, driving operational excellence, and

Full-time

Compensation information provided in the description

Trade Compliance Analyst

Remote or New York, New York

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Today

Title: - Trade Compliance Analyst Location: New York, NY, 10001 Duration: 12 months (possible for extensions) Fully Remote Position Job Description: Trade Compliance Analyst Position Summary: The Trade Compliance Analyst is responsible for supporting U.S. import compliance activities and ensuring adherence to U.S. Customs regulations and Partner Government Agency (PGA) requirements. This role partners with customs brokers, government agencies, logistics providers, and internal stakeholders to

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Contract, Third Party

$Market

Quality Operations Specialist I

Irvine, California

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Today

Biomedical / Electrical / Mechanical Engineer - Medical Device Quality Location: Irvine, CA Job Type: Contract with Health and 401k benefits Duration: 1 year Schedule: M - F, 8-5 Experience: 2+ years We are seeking an early-career Biomedical, Electrical, or Mechanical Engineer to support quality and technical investigations for medical devices. This is a hands-on opportunity for an engineer who enjoys troubleshooting products, investigating technical issues, documenting findings, and worki

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Contract

$35.27 - $40.82

Design Quality Engineer (Onsite in Santa Clarita, CA)

Hybrid in Santa Clarita, California

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Today

Sr. Medical Device Design & Manufacturing Quality Engineer Needed. Onsite in Santa Clarita, CA. 6 month contract. Role: Ensure medical-device products are designed safely, transferred into manufacturing correctly, manufactured consistently, and supported by documentation that satisfies FDA/ISO requirements. Lead investigation, assess risk, determine root causes if needed. Experience Needed: Prior experience designing assurance / manufacturing quality engineering for medical devices to meet des

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Full-time, Contract, Third Party

$65 - $80 per hour

Fda jobs in California, USA