Regulatory Affairs jobs in Hercules, CA

San Francisco, California

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26d ago

Title: Director, Regulatory Affairs Location: San Francisco Bay Area (Onsite) Job Description: Reports into Regulatory Affairs, Global Filing & Registration: High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.Develop strate

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Contract

$90 - $100

Regulatory Affairs Specialist

Remote

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10d ago

About Nexinfo NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design and advanced software solutions. Our ERP-related services address challenges such as invent

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Third Party, Contract

$60 - $70

Regulatory Affairs Data Coordinator

Remote or Irvine, California

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Today

Kelly Science and Clinical FSP is currently seeking an RA Data Coordinator for a long-term engagement in Irvine, CA with one of our Global clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eli

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Contract

Senior Spectrum Engineer, Regulatory Affairs

Remote or Carlsbad, California

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Today

About us One team. Global challenges. Infinite opportunities. At Viasat, we're on a mission to deliver connections with the capacity to change the world. For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries around the globe communicate. We're looking for people who think big, act fearlessly, and create an inclusive environment that drives positive impact to join our team. What you'll do As a pivotal member of Viasat's global regulatory team, you

Full-time

USD 180,500.00 - 285,000.00 per year

Senior Software Engineer - Mercury Command

San Francisco, California

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Yesterday

In 1965, an engineer in Scotland was given a mundane task with a tricky problem to it - banks wanted to close on Saturdays and still serve customers, but they didn't know how to solve the authentication of the right user. James Goodfellow, working at Smiths Industries, uncovered the insights that you needed something you have (a card) and something you know (a PIN). Because someone told him they could only remember 4 digits instead of his proposed 6, today over 3 million ATMs use a card+4 digit

Full-time

USD 200,700.00 - 250,900.00 per year

Head of Data Engineering & Platform

San Francisco, California

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Yesterday

In the early 1970s, Ken Thompson and Dennis Ritchie built Unix around a deceptively simple idea: create small, composable tools that work well together. That philosophy went on to shape modern operating systems, developer tooling, cloud infrastructure, and much of the software we rely on today-not because any individual tool was revolutionary, but because the platform made everyone else more productive. We're looking for a Head of Data Engineering & Platform who can build the data platform that

Full-time

USD 289,700.00 - 362,100.00 per year

Regulatory Specialist

Remote

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3d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

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Contract

Depends on Experience

Senior Machine Learning Operations Engineer

San Francisco, California

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Yesterday

Mercury's use of machine learning in risk decisioning is growing fast in scope and in stakes. Models increasingly drive real-time decisions about fraud and financial crime, and the Machine Learning Platform (MLP) team exists to build a paved path from a trained model to a reliable production deployment, speeding up iteration, and ensuring granular production observability. MLP owns the production ML lifecycle: the systems that take a model from registry through deployment, real-time inference,

Full-time

USD 166,600.00 - 208,300.00 per year

CSV Engineer

San Francisco, California

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Today

Roles & Responsibilities: Develop and implement validation strategies for computer systems and software applications. Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports. Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems. Conduct validation tes

Full-time

CAPA/QMS Quality Engineer (On-Site)(No Corp to Corp or H-1B)

Pacheco, California

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Today

Please note that this is a 12-18 Month Contract and is On-Site. No Corp to Corp or H-1B. JOB DESCRIPTION: Education: Science or Engineering: BS/MS/PhD or equivalent industry experience Required Experience: Minimum 5 years working in a Quality Engineer role in a regulated industry and experience interfacing with regulatory bodies Strong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR Operations or Quality Experience in Medical Device Manufactur

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Contract

Depends on Experience

Lead Cyber Security Architect

Hercules, California

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Today

The Technical Leader for the Product Cybersecurity Program and Product Security Incident Response Team (PSIRT) provides leadership for medical device cybersecurity across Bio-Rad's Clinical Diagnostics portfolio. This role owns the strategy, governance, and execution of the product cybersecurity program, ensuring compliance with FDA cybersecurity requirements and global standards while driving program maturity across the organization and product lifecycle. This position serves as the authoritati

Full-time

USD 179,400.00 - 246,600.00 per year

Lead Software Engineer, PKI & Cryptographic Trust Services

San Francisco, California

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Today

To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Software Engineering Job Details About Salesforce Salesforce is the #1 AI CRM, where humans with agents drive customer success together. Here, ambition meets action. Tech meets trust. And innovation isn't a buzzword - it's a way of life. The world of work as we know it is changing and we're looking for Trailblazers who are passionate

Full-time

USD 172,500.00 - 260,100.00 per year

Regulatory Specialist

Remote or Raynham, Massachusetts

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Today

Kelly Science and Clinical FSP is currently seeking a Regulatory Specialist for a long-term engagement with one of our Global MedTech clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible

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Contract

Regulatory Affairs Specialist Small Molecule

Remote

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7d ago

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

Market Research & Data Analytics Intern

San Francisco, California

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Today

Join the leader in entertainment innovation and help us design the future. The Dolby U internship program offers impactful, project-based work experience in a collaborative, creative environment where you work side by side with industry leaders. Amplify your insatiable curiosity by implementing real-world solutions that revolutionize how people communicate and how entertainment is created, delivered, and enjoyed worldwide. We offer a collegial culture, challenging projects, and excellent compens

Full-time

USD 33.00 - 38.00 per hour

Senior Test Engineer

San Francisco, California

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Today

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integr

Full-time

USD 165,000.00 - 205,000.00 per year

Project Manager

Remote or West Chester, Pennsylvania

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Today

Kelly Science and Clinical FSP is currently seeking a Project Manager - Business Split Transfer & Implementation for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benef

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Contract

Senior Engineer (Mechanical)

Remote

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Today

Overview Please note that this position is contingent upon the successful award of a contract currently under bid. Nisga'a CIOPS delivers cleared professionals to support civilian and DoD customers worldwide across intelligence support, cyber/defensive cyber operations, IT O&M, infrastructure modernization, training, and logistics. Summary: The Senior Engineer (Mechanical) provides mechanical engineering support to DOJ/BOP facilities stakeholders by performing technical analyses, document rev

Full-time

USD 100,000.00 - 170,000.00 per year

Senior Engineer (Architect)

Remote

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Today

Overview Please note that this position is contingent upon the successful award of a contract currently under bid. Nisga'a CIOPS delivers cleared professionals to support civilian and DoD customers worldwide across intelligence support, cyber/defensive cyber operations, IT O&M, infrastructure modernization, training, and logistics. Summary: The Senior Engineer (Architect) provides architectural engineering support to DOJ/BOP facilities stakeholders by performing technical analyses, document r

Full-time

USD 100,000.00 - 170,000.00 per year

Data Center Design (Hyperscale) - Architect

Remote

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Today

At OnQGlobal, we hire GREAT PEOPLE who do GREAT WORK for GREAT CLIENTS. Our team members are consummate professionals trusted by Fortune 100 companies across the semiconductor, cleanroom, advanced manufacturing, and mission-critical data center industries. Our mission is to deliver exceptional service with integrity, professionalism, and a collaborative spirit, enabling our clients to achieve excellence on a global scale. Role Overview: We are seeking a highly motivated and experienced Data Ce

Full-time

Regulatory Affairs jobs in Hercules, CA, USA