Regulatory Affairs Jobs in Boston, MA

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Regulatory Affairs Specialist- 100% remote in FL

ConsultNet, LLC

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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
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Posted 22 days ago | Updated 1 hour ago

Senior Process Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Responsibilities: This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site. Develop and execute current state operational readiness assessment pFMEAs. Report findings with recommendations and escalate critical risks/gaps identified timely. Support resolution of identified gaps
Posted 60+ days ago | Updated 2 hours ago

Product Safety Engineer

SharkNinja

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Needham, Massachusetts, USA

Full-time

About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market, and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains
Posted 2 days ago | Updated 18 hours ago

Principal C++ Software Engineer - Med Device

Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

Our client is an innovative, venture-backed medical technology company developing next-generation imaging solutions to enhance surgical precision and improve patient outcomes. They are seeking a Principal Software Engineer with deep expertise in C++, CUDA, and image processing to help lead development of real-time imaging software for surgical applications. Position Summary: This role will focus on designing and optimizing software systems that utilize visible and near-infrared imaging technolo
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Posted 34 days ago | Updated 10 hours ago

Senior Engineer, Design Transfer Specialist

Amgen Inc

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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
Posted 60+ days ago | Updated 2 hours ago

Associate Engineering Fellow, Process Engineering

Takeda pharmaceutical

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Cambridge, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Synthetic Molecule Process Development (SMPD) is responsible for the development of robust, sustainable, and cost-effective processes
Posted 60+ days ago | Updated 2 hours 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 8 days ago | Updated 2 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

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New Jersey, USA

Third Party, Contract

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 9 days ago

Engineer III, Validation

Thermo Fisher Scientific

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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
Posted 57 days ago | Updated 2 hours ago

Associate Director - Hematology, Oncology Data Sciences & Digital Health

Johnson & Johnson

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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
Posted 33 days ago | Updated 2 hours ago

Senior Manager, Data Analytics

Quest Diagnostics Inc.

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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
Posted 19 days ago | Updated 1 day 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 58 days ago | Updated 2 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 2 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

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
Posted 11 days ago | Updated 2 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 1 hour ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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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
Posted 47 days ago | Updated 2 hours ago

Sr. Director, Cyber Warfare Business Development

Parsons Services Company

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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
Posted 60+ days ago | Updated 1 hour ago

Controls Assessment & Testing Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATION

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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