regulatory affairs Jobs in california

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Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated moments ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 24 days ago | Updated moments ago

Senior Principal Systems Safety Engineer (Hybrid)

RTX Corporation

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Remote or Cedar Rapids, Iowa, USA

Full-time

Date Posted: 2025-05-12 Country: United States of America Location: HIA32: Cedar Rapids, IA 400 Collins Rd NE , Cedar Rapids, IA, 52498-0505 USA Position Role Type: Hybrid U.S. Citizen, U.S. Person, or Immigration Status Requirements: The ability to obtain and maintain a U.S. government issued security clearance is required.Security Clearance: DoD Clearance: Secret Collins Aerospace is seeking an experienced System Safety Engineer within our Missions Systems organization. This engineer will b
Posted 60+ days ago | Updated moments ago

Principal Software Engineer - Urology R&D (Mobile Applications)

Boston Scientific Corporation

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Irvine, California, USA

Full-time

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your
Posted 23 days ago | Updated moments ago

Principal Software Engineer - Urology

Boston Scientific Corporation

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Irvine, California, USA

Full-time

Innovation - Diversity - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the Role:
Posted 55 days ago | Updated moments ago

Senior Engineer, Design Transfer Specialist

Amgen Inc

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Remote or Cambridge, Massachusetts, USA

Full-time

Career Category Operations Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each
Posted 60+ days ago | Updated moments ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 60+ days ago | Updated moments ago

Sr. Director, Cyber Warfare Business Development

Parsons Services Company

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Remote

Full-time

In a world of possibilities, pursue one with endless opportunities. Imagine Next! When it comes to what you want in your career, if you can imagine it, you can do it at Parsons. Imagine a career working with exceptional people sharing a common quest. Imagine a workplace where you can be yourself. Where you can thrive. Where you can find your next, right now. We've got what you're looking for. Job Description: Parsons is looking for an amazingly talented Sr. Director, Cyber Warfare Business De
Posted 60+ days ago | Updated moments ago

Principal R&D Software Engineer - Shockwave

Johnson & Johnson

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Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 60+ days ago | Updated moments ago

Controls Assessment & Testing Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATION

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Remote or Buffalo, New York, USA

Full-time

The Bank sponsors individuals for TN and H-1B transfers on a case by case basis. Please note that this position is not open to anyone on a H-1B or F-1 student visa including those eligible for CPT/OPT or the Stem OPT extension. Overview: Leads risk analysis for complex initiatives, influencing overarching risk framework and providing advanced guidance to leadership for informed decision-making aligned with organizational imperatives. Primary Responsibilities: Develop and implement strategic ap
Posted 60+ days ago | Updated moments ago

Senior COBOL Developer

General Dynamics

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Sacramento, California, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: None Job Family: Programming Job Qualifications: Skills: Applications Programming, CICS COBOL, Mainframe Software Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: Senior Cobol Developer We are GDIT. The people supporting and securing some of the most complex government, defense, and intellig
Posted 60+ days ago | Updated moments ago

RIMS platforms Business Analyst

ASCII Group LLC

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San Jose, California, USA

Contract, Third Party

The following requirement is open with our client. Title : RIMS platforms Business Analyst Location : San Jose, CA Duration : 12Months Detailed Job Description: Serve as the primary point of contact for regulatory and IT stakeholders.Gather, document, and validate business requirements for RIMS enhancements and integrations.Oversee system validation, UAT coordination, and compliance documentation.Manage vendor relationships and ensure offshore teams meet SLAs and KPIs.Ensure alignment with GxP,
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Posted 4 days ago

Compliance Lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
Easy Apply
Posted 5 days ago | Updated 6 hours ago

Scientist I, CMC Analytical Development

Tandym Tech

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South San Francisco, California, USA

Contract, Third Party

We have a current opportunity for a Scientist I, CMC Analytical Development on a contract basis. The position will be based onsite in San Fransisco, CA. For further information about this position please apply. CMC Analytical Development is looking for a Scientist to join the Technical Development department expand its biologics based pipeline. The hired scientist will develop physicochemical analytical methods (HPLC, CE, LC/MS), perform extensive characterization on both early and late stage m
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Posted 12 days ago | Updated moments ago

Quality Management Systems (QMS) Specialist (W2)

Sovereign Technologies

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Irvine, California, USA

Contract

Title: Document Control Coordinator - QMS Location: Irvine, CA Onsite Document Control Specialist QMS Job Description We are seeking a dedicated Quality Management Systems (QMS) Specialist who will play a crucial role in ensuring compliance with internal and external regulatory requirements. This role involves engaging in the development of future state QMS for business needs, executing modifications, and contributing to the quality planning process. Responsibilities Ensure QMS compliance with a
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Posted 48 days ago | Updated 14 days ago