Regulatory Affairs Jobs in San Jose, CA

1 - 20 of 27 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

Senior Regulatory Affairs Licensing Engineer (remote eligible)Job Title - Senior Regulatory Affairs Licensing Engineer (remote eligible)

GE VernovaCompany Name - GE Vernova

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Remote

Full-time

Job Description Summary The Regulatory Affairs Lead Licensing Engineer will lead the completion of various regulatory work scopes, including working with GEH / GNF Engineering on major projects for the existing fleet of nuclear reactors. Guided by professional practices and policies that are shaped by the role. The role has moderate autonomy, requiring high levels of operational judgment. Job Description Essential Responsibilities As a Senior Regulatory Affairs Licensing Engineer you will: Coo

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

Principal Systems EngineerJob Title - Principal Systems Engineer

Abbott LaboratoriesCompany Name - Abbott Laboratories

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Pleasanton, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full li

Principal Systems EngineerJob Title - Principal Systems Engineer

Abbott LaboratoriesCompany Name - Abbott Laboratories

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Pleasanton, California, USA

Full-time

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

•

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

Systems Engineer IJob Title - Systems Engineer I

Abbott LaboratoriesCompany Name - Abbott Laboratories

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Pleasanton, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Job Title Systems Engineer I Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your tru

Regulatory CMS Senior ManagerJob Title - Regulatory CMS Senior Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

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Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years) Good communications skills (written/verbal) Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or hig

Classification and Trade Data Specialist (Mid-Level or Senior)Job Title - Classification and Trade Data Specialist (Mid-Level or Senior)

Boeing CompanyCompany Name - Boeing Company

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Remote or Dallas, Texas, USA

Full-time

Classification and Trade Data Specialist (Mid-Level or Senior) Company: The Boeing Company The Boeing Company is seeking a Classification and Trade Data Specialist (Mid-Level or Senior) to join their team in Dallas, TX. This role ensures our products are accurately classified for importation and exportation from our nine global warehouse locations. The candidate will have a strong knowledge of established classification methodologies utilizing the Harmonized Tariff Schedule and Order of Revie

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

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

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 Engineer, R&D NPI LeadJob Title - Principal Engineer, R&D NPI Lead

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Jacksonville, Florida, USA

Full-time

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

Apptad IncCompany Name - Apptad Inc

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New Jersey, USA

Contract, Third Party

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

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

Sr. Principal Engineer, R&DJob Title - Sr. Principal Engineer, R&D

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Raritan, New Jersey, USA

Full-time

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