regulatory affairs Jobs in san diego, ca

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Manager Regulatory Affairs

Sureminds Solutions

Remote

Third Party, Contract

C2C Role Please share Profiles at Hi, Urgent need, Manager Regulatory Affairs, Structured Product Labelling (SPL) for USA market Remote role Max rate is $55/hr on c2C Job Description: Manager Regulatory Affairs, Structured Product Labelling (SPL) for USA market In this role Candidate should have experience in regulatory affairs while essential exposure to Structured Product Labelling (SPL) for assigned products and also need to have good knowledge of labelling requirements for USA market. In de

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

HUMAC INC.

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 FL

ConsultNet, LLC

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

Global Regulatory Operations Lead Consultant Department

Sureminds Solutions

Remote

Contract, Third Party

Please share Profiles at Hi, Urgent need, Job Title: Global Regulatory Operations Lead Consultant Department Remote Role Max rate is $42/hr on c2c Job Description: Experience Typically a minimum of -3 years relevant regulatory experience within a regulatory function Experience with RIM, Submission Management or Publishing tools Competencies Strong Knowledge and demonstrated understanding of following: o Genpact Regulatory Standards o Genpact Regulatory Practice o Departmental standard operati

Data Risk Appetite Sr Group Manager, Director

Citi

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 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

Engineer III, Validation

Thermo Fisher Scientific

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 Health

Johnson & Johnson

Remote or New Brunswick, 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

Senior Manager, Data Analytics

Quest Diagnostics Inc.

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 Engineer, R&D Compliance

ICU Medical, Inc.

Remote

Full-time

Job Description Position Summary This position is responsible for leading regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with global medical device standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, and ISO 14971. Essential Duties & Responsibilities Material Compliance & Restricted Substances: Lead and manage EU MDR-related DHF remediation activities with a focus on legacy material compliance and regulatory gap assessments. Au

Product Owner/Manager- Medical

INSPYR Solutions

Remote or Santa Clara, California, USA

Contract

About the Role We are seeking an experienced and driven Product Owner/Manager with a strong background in medical hardware product development . This role is critical in bridging the gap between clinical needs, engineering, regulatory requirements, and market demands to ensure delivery of high-impact, safe, and effective medical devices. The ideal candidate will possess a deep understanding of the medical hardware lifecycle, from concept through commercialization, including regulatory pathways (

Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATION

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 Systems

Katalyst Healthcares and Lifesciences

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 CAD Technician

Johnson & Johnson

Remote or Palm Beach Gardens, 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

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

Senior Principal Systems Safety Engineer (Hybrid)

RTX Corporation

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 Specialist

Amgen Inc

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 Architect

Gilead Sciences, Inc.

Remote or Santa Monica, 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

Sr. Director, Cyber Warfare Business Development

Parsons Services Company

Remote

Full-time

In a world of possibilities, pursue one with endless opportunities. Imagine Next! When it comes to what you want in your career, if you can imagine it, you can do it at Parsons. Imagine a career working with exceptional people sharing a common quest. Imagine a workplace where you can be yourself. Where you can thrive. Where you can find your next, right now. We've got what you're looking for. Job Description: Parsons is looking for an amazingly talented Sr. Director, Cyber Warfare Business De

Controls Assessment & Testing Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATION

Remote or Buffalo, New York, USA

Full-time

The Bank sponsors individuals for TN and H-1B transfers on a case by case basis. Please note that this position is not open to anyone on a H-1B or F-1 student visa including those eligible for CPT/OPT or the Stem OPT extension. 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 ap