Regulatory Affairs Jobs in California

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Senior Regulatory Affairs Specialist

ZennSoft

•

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
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Posted 15 days ago

Regulatory CMS Senior Manager

Sureminds Solutions

•

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
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Posted 2 days ago | Updated 1 day ago

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

Boeing Company

•

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
Posted 3 days ago | Updated 2 hours ago

Engineering Project Manager III - Standalone Accessories

Russell, Tobin & Associates

•

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
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Posted 8 days ago | Updated moments ago

Data Risk Appetite Sr Group Manager, Director

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
Posted 15 days ago | Updated 2 hours ago

Senior Process Engineer III

Katalyst Healthcares and Lifesciences

•

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:
Posted 53 days ago | Updated 2 hours ago

Principal Engineer, R&D NPI Lead

Johnson & Johnson

•

Remote or Jacksonville, Florida, 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 4 days ago | Updated 3 hours ago

Engineer

Katalyst Healthcares and Lifesciences

•

Los Angeles, California, USA

Full-time

Roles & Responsibilities: 4-6 years Minimum bachelor's or master's degree in a health-care related field Strong knowledge of GMP (Good Manufacturing Practices) and ISO 13485 standards, along with regulatory affairs. Strong creative, analytical, and problem-solving skills. Proficient in interpreting data and compiling detailed reports. Expertise in Design Quality, Good Manufacturing Practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, and Manufacturing Processes. Expertis
Posted 60+ days ago | Updated 2 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

•

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
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Posted 16 days ago

Process Engineer

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. Responsibilities: Design History File: Ensure that the transferred process is adhering to t
Posted 60+ days ago | Updated 2 hours ago

Architectural Manager - Quality Assurance & Permitting

Disneyland Resort

•

Anaheim, California, USA

Full-time

Walt Disney famously said, "You can dream, create, design and build the most wonderful place in the world, but it takes people to make the dream a reality." At Disney, our cast are the key to the magic, and we work together to inspire the future generations of guests that visit our theme parks and attractions worldwide. As a critical part of our creative, problem-solving team, you will have a hand in the jar of pixie dust, pushing the limits of entertainment design, innovation and themed archite
Posted 2 days ago | Updated 20 hours ago

Process Engineer

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
Posted 60+ days ago | Updated 2 hours ago

Process Manufacturing Engineer

Katalyst Healthcares and Lifesciences

•

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
Posted 56 days ago | Updated 2 hours ago

Senior Specialist - Technology and Cybersecurity Risk

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
Posted 60+ days ago | Updated 2 hours ago

Project Manager - IT - II*

HAYS

•

San Francisco, California, USA

Contract

Project Manager - IT - II* - Contract - San Francisco, CA - $69.86 - $69.86/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is
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Posted 48 days ago | Updated 11 hours ago

Sr. Principal Engineer, R&D

Johnson & Johnson

•

Remote or Raritan, New Jersey, 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 14 hours ago | Updated 3 hours ago

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 3 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

•

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 18 days ago | Updated 3 hours 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 2 hours ago

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

Boston Scientific Corporation

•

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 17 days ago | Updated 3 hours ago