UNKNOWN

FEED

Knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, IVDR and import/export requirements. Key Responsibilities: The Regulatory Affairs Specialist II will join existing team and provide support for International Registration of IVD products.

HOUR

Indotronix International Corporation

Regulatory Affairs Specialist II

Reporting to the Program Management & Operations organization, the CMC Project Manager partners with CMC, Manufacturing, Analytical Development, Quality, Regulatory Affairs, Supply Chain, Clinical Supply, Clinical Development, Commercial, Finance, Procurement, and external partners to integrate timelines, risks, dependencies, budgets, and technical decisions into unified project plans. Develop, maintain, and communicate detailed CMC project plans for assigned programs, including milestones, dependencies, critical-path activities, document workflows, key cGMP deliverables, stability pulls and reports, regulatory commitments, and cross-functional deliverables.

Intuitive Surgical Inc

Project Manager, CMC

The Manager, Field Action Process is responsible for managing Cepheid’s global Field Action process and ensuring consistent, compliant execution of field actions, recalls, corrections, removals, field safety corrective actions, customer notifications, and related post-market actions. The Manager will drive disciplined daily management, timely escalation, continuous improvement, and cross-functional coordination to ensure field action activities are executed in accordance with applicable FDA, ISO 13485, EU IVDR/MDR, and other global regulatory expectations.

YEAR

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Danaher

Manager, Field Action Process

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The New Product Development (NPD) Engineering Manager is a technical leadership role within the Research & Development organization responsible for leading the engineering execution and technical strategy of assigned medical device product lines from concept through commercialization. Drive product risk management and technical decision-making, partnering with Design Assurance to identify, assess, mitigate, and document product risks while leading technical reviews and resolving complex engineering challenges.

Galvanize Therapeutics

Manager, New Product Development

The Project Manager will collaborate with Quality, Manufacturing, Validation, IT, Regulatory Affairs, Engineering, and external vendors to successfully deliver projects on schedule, within budget, and in compliance with regulatory requirements. We are seeking an experienced GxP Project Manager to lead and manage cross-functional GxP initiatives supporting pharmaceutical manufacturing, quality, laboratory, validation, and IT systems.

Karwell Technologies

GxP Project Manager

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Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Intuitive Surgical

Sr. Program Manager

Functionally, work includes: Identifying critical path milestones and developing project plans/timelines with ISI functions, including Global Commercial leadership, Project Management Office, Customer Success, Trade Compliance, Global Logistics, Regulatory Affairs, Product Quality, and various shared service organizations. U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Senior Project Manager, Portfolio Lifecycle Operations

Collaborate effectively with biomarker, bioinformatics, and companion diagnostic (CDx) scientists on reviews of protocols, informed consent forms (ICFs), electronic case report forms (eCRFs), data transfer specifications (DTS), Genomic Verification Forms, and electronic trial master file (eTMF) documentation to ensure operational alignment and successful collection and testing of clinical trial samples. The Opportunity: As a Senior Manager, Clinical Biomarker Operations (CBO) within the Translational Medicine function, you will provide biomarker operational expertise, develop scope of work (SOW), and maintain effective working relationships with cross-functional teams supporting Phase I-III clinical trials.

Revolution Medicines, Inc.

Senior Manager, Clinical Biomarker Operations

The compensation range for this position is specific to the location, experience and level and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors. Develop and implement program metrics, dashboards, and status reporting so that team commitments (scope, schedule, resources) are tracked and communicated clearly to stakeholders and leadership.

SI-BONE, Inc

Project Manager

GreenHouseAPI

Leveraging its expertise and resources, Hitachi Americas and its subsidiary companies operate across diverse sectors, including transportation, energy, mobility, industrial manufacturing, healthcare, digital engineering, data analytics and others. Through its Social Innovation Business (SIB) that brings together IT, OT(Operational Technology) and products, Hitachi aims to be a global leader in continuously transforming social infrastructure through digital, contributing to a harmonized society where the environment, wellbeing, and economic growth are in balance.

Hitachi Ltd

Manager, State Growth and Government Outreach

Create and operationalize a comprehensive technical strategy and integrated roadmap for Freenome's data products, pipelines, and tooling while aligning cross-functional milestones and deliverables across current and future programs. This role will lead discussions with key-decision makers and stakeholders to create a comprehensive data platform roadmap outlining Freenome's path to commercialization and support for ongoing product development.

Freenome Inc

Technical Product Manager III

Kitchell seeks an experienced and dedicated Project Manager II to join our Bay Area region in the city of South San Francisco and build a long-term career at one of the most innovative and growth-oriented building companies in the United States. While performing the duties of this job, the employee must regularly sit, stand, walk, talk or hear and use hands to finger, feel and handle; frequently reach with hands and arms; occasionally climb or balance and stoop, kneel, crouch or crawl.

Kitchell Corporation

Project Manager II

Kitchell seeks experienced and dedicated Senior Project Managers to join our Bay Area region in the city of South San Francisco and build a long-term career at one of the most innovative and growth-oriented building companies in the United States. While performing the duties of this job, the employee must regularly sit, stand, walk, talk or hear and use hands to finger, feel and handle; frequently reach with hands and arms; occasionally climb or balance and stoop, kneel, crouch or crawl.

Senior Project Manager

This is an incredible opportunity for a senior technologist looking to step into leadership, or an experienced supervisor ready to make a significant impact in a collaborative, patient-centric environment. This is a "working manager" role where you will split your time between supervising staff and directly participating in imaging procedures (dependent on your specific licensure).

Enigma Search

Assistant Manager, Imaging Services

The successful candidate will be an organized and detail-oriented self-starter with experience in Operations Management, Logistics, and Bath/Shower Installation (preferably candidates from the home improvement industry). 5+ years of proven experience as an Operations Manager or similar leadership role, preferably within the One Day Bath or related home improvement industries.

Jacuzzi Group

Sr. Production Manager

They will bring structure to complex problems, translate the needs of Program Managers and molecule teams into scalable solutions, and drive adoption of tools and processes that improve visibility, consistency, and effectiveness across programs. This role will partner closely with Program Managers and cross-functional molecule teams to understand business needs and develop practical processes, tools, and ways of working that enable effective planning, collaboration, and execution.

Program Management Office Manager

This person partners closely with cross-functional leaders (Software, Mechanical, Systems, Quality/Regulatory, Manufacturing) to align electrical engineering strategy with business unit and corporate priorities, and to ensure programs meet Intuitive''s quality system and FDA regulatory requirements throughout the medical device development lifecycle. Independently establish objectives, schedules, budgets, and resource plans for the organization; negotiate resources and priorities with other functional and resource managers: Set team and departmental goals aligned to business unit strategy; anticipate interdependencies and avoid surprises through proactive planning and risk management.

Sr. Manager, Electrical Engineering

Completes Hazard Analysis and Risk Based Preventative Controls (HARPC) Preventative Controls for Human Food training and certification course to be a PCQI "Preventive Controls Qualified Individual" according to company policy. Number of Direct Reports: Number of Dotted Line Reports: Estimated Total Size of Team: gategroup Competencies Required to be Successful in the Job: Thinking- Information Search and analysis & problem resolution skills.

<p>Gate Gourmet is the world’s largest independent provider of airline catering and provisioning services. We are also very active in adjacent markets.
With more than sixty years of experience in providing appealing food and beverage options, designed to fit any budget, we offer: A wide range of culinary solutions
"Last mile" provisioning to aircraft
Catering and provisioning services for non-airline business, such as railway companies, lounges, and convenience retailersGate Gourmet is the core business behind gategroup, whose ten associated companies offer customers a comprehensive scope of products and services for virtually any onboard need - from innovative menu design to stylish packaging to sophisticated supply chain solutions.</p>

Gate Gourmet

QA Manager

To serve as a trusted operational partner to the General Manager, delivering exceptional hospitality, disciplined cost management, strong team performance, and consistent restaurant and event execution while supporting the overall financial and service objectives of Infuse Hospitality at the San Francisco Design Center. The Assistant General Manager (AGM) is a key operational leader supporting the General Manager in overseeing restaurant, beverage, catering, and event operations at the San Francisco Design Center.

Infuse Hospitality

Assistant General Manager

Chattr

Bring your talents to Ross, our leading off-price retail chain with over 2,200 stores, and a strong track record of success and growth. Our focus has always been bringing our customers a constant stream of high-quality brands and on-trend merchandise at extraordinary savings.

Regulatory Manager Jobs in Redwood City, CA

Regulatory Affairs Specialist II Indotronix International Corporation

Project Manager, CMC Intuitive Surgical Inc

Manager, Field Action Process Danaher

Manager, New Product Development Galvanize Therapeutics

GxP Project Manager Karwell Technologies

Sr. Program Manager Intuitive Surgical

Senior Project Manager, Portfolio Lifecycle Operations Intuitive Surgical Inc

Senior Manager, Clinical Biomarker Operations Revolution Medicines, Inc.

Project Manager SI-BONE, Inc

Manager, State Growth and Government Outreach Hitachi Ltd

Technical Product Manager III Freenome Inc

Project Manager II Kitchell Corporation

Senior Project Manager Kitchell Corporation

Assistant Manager, Imaging Services Enigma Search

Sr. Production Manager Jacuzzi Group

Program Management Office Manager Revolution Medicines, Inc.

Sr. Manager, Electrical Engineering Intuitive Surgical Inc

QA Manager Gate Gourmet

Assistant General Manager Infuse Hospitality

Sr. Manager, IT Marketing Technology Ross Stores Inc

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