regulatory affairs Jobs in san jose, ca

1 - 20 of 23 Jobs

Senior Regulatory Affairs SpecialistJob Title - Senior Regulatory Affairs Specialist

ZennSoftCompany Name - ZennSoft

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Union City, California, USA

Full-time

Job Title: Senior Regulatory Affairs (RA) Specialist Location: Union City, CA Industry: Medical Devices / Regulatory Affairs Employment Type: Full-Time Client: Lhasa OMS, Inc. About the Role Lhasa OMS, Inc. is seeking a highly motivated Senior Regulatory Affairs Specialist to join our team in Union City, CA. The ideal candidate will support the Regulatory Affairs department by preparing and submitting regulatory documentation for medical devices in both domestic and international markets. This p

Structured Product Labeling(SPL), Regulatory Affairs--New Jersey(Remote)Job Title - Structured Product Labeling(SPL), Regulatory Affairs--New Jersey(Remote)

HUMAC INC.Company Name - HUMAC INC.

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Remote

Contract

Hello, I Hope you are doing well. This is Surya from Humac Inc., Please check the following job description, and if you are interested, or know someone who might be interested, please share your updated resume to reach you. Role: Structured Product Labeling(SPL), Regulatory Affairs Location: New Jersey(Remote) Duration of the project: 12+ Months Contract Responsibilities Review of SPLs content labelling Submission of SPLs content labelling Monitoring of recent updates in SPL Escalate, notify and

Regulatory Affairs Specialist- 100% remote in FLJob Title - Regulatory Affairs Specialist- 100% remote in FL

ConsultNet, LLCCompany Name - ConsultNet, LLC

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Remote or Florida, USA

Full-time

Regulatory Affairs Specialist 100% Remote from anywhere in Florida 6+ month contract to hire $38.50- $52.00 an hour ($80k- $110k salary upon conversion) Immediate hire with growing company. The Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presente

Engineering Project Manager III - Standalone AccessoriesJob Title - Engineering Project Manager III - Standalone Accessories

Russell, Tobin & AssociatesCompany Name - Russell, Tobin & Associates

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Cupertino, California, USA

Full-time, Contract

The Engineering Team at Russell Tobin & Associates is supporting a leading technology company that has an opening for Engineering Project Manager - Standalone Accessories near Cupertino, CA. Responsibilities: Manage end-to-end accessory development (NPI EOL) Lead cross-functional teams (Engineering, Ops, Marketing, CM/OEMs) Own schedules, FAIs, logistics, and configuration (ECOs, BOMs, AML) Ensure trade compliance, consumer safety, and global readiness Drive communication, resolve issues, and

Senior Process Engineer IIIJob Title - Senior Process Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Dublin, California, USA

Full-time

Responsibilities: Design History File: Ensure that the transferred process is adhering to the Device Master Record. Process Analysis and Documentation: Analyse current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities. Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure smooth transition between facilities. Cross-functional Collaboration:

Process EngineerJob Title - Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Dublin, California, USA

Full-time

Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules. Responsibilities: Design History File: Ensure that the transferred process is adhering to t

Process EngineerJob Title - Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Dublin, California, USA

Full-time

Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules.Key Responsibilities: Design History File: Ensure that the transferred process is adhering t

Process Manufacturing EngineerJob Title - Process Manufacturing Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Dublin, California, USA

Full-time

Job Description: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules. Responsibilities: Design History File: Ensure that the transferred process is adheri

Data Risk Appetite Sr Group Manager, DirectorJob Title - Data Risk Appetite Sr Group Manager, Director

CitiCompany Name - Citi

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Remote or New York, New York, USA

Full-time

The Data Risk Appetite Sr Group Manager, Director is a senior level role managing a team responsible for facilitating all aspects of the Enterprise Data Risk and Control Framework and Data Risk Taxonomy. This role is responsible for Quarterly : Top Risk Alignment : Data Risk metricsRisk Appetite AssessmentScenario Analysis and Lessons LearnedData Risk ProfileMetric Adequacy AssessmentRisk Appetite analyticsMetric Maturity AssessmentMetric Coverage of the categoryIssues : thematic analysisLosses

Sr Manager, IT Business Analysis - SAP BRH ArchitectJob Title - Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.Company Name - 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

Principal R&D Software Engineer - ShockwaveJob Title - Principal R&D Software Engineer - Shockwave

Johnson & JohnsonCompany Name - 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

Principal Regulatory Consultant Dietary SupplementsJob Title - Principal Regulatory Consultant Dietary Supplements

Apptad IncCompany Name - Apptad Inc

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New Jersey, USA

Third Party, Contract

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Associate Director - Hematology, Oncology Data Sciences & Digital HealthJob Title - Associate Director - Hematology, Oncology Data Sciences & Digital Health

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or New Brunswick, New Jersey, USA

Full-time

Senior Manager, Data AnalyticsJob Title - Senior Manager, Data Analytics

Quest Diagnostics Inc.Company Name - Quest Diagnostics Inc.

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Remote or Wood Dale, Illinois, USA

Full-time

Overview Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function. This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting. This is a highly vi

Senior Specialist - Technology and Cybersecurity RiskJob Title - Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATIONCompany Name - M&T BANK CORPORATION

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Remote or Buffalo, New York, USA

Full-time

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 approaches for in-depth risk assessments for comprehensive coverage of all technology capabilities.Develop and execute sophisticated risk management framework and programs that informs how to align practices with business objective

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - 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

Senior Principal Systems Safety Engineer (Hybrid)Job Title - Senior Principal Systems Safety Engineer (Hybrid)

RTX CorporationCompany Name - 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

Senior Engineer, Design Transfer SpecialistJob Title - Senior Engineer, Design Transfer Specialist

Amgen IncCompany Name - 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

Sr. Manager, SAP CGTO Solutions ArchitectJob Title - Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.Company Name - Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time