regulatory affairs Jobs in minneapolis, mn

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Senior Engineer, R&D Compliance

ICU Medical, Inc.

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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
Posted 4 days ago | Updated 9 hours ago

Product Owner/Manager- Medical

INSPYR Solutions

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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 (
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Posted 1 day ago | Updated moments 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 51 days ago | Updated 9 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 9 hours ago

Senior CAD Technician

Johnson & Johnson

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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
Posted 25 days ago | Updated 9 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 5 days ago | Updated 9 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 59 days ago | Updated 9 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 9 hours 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 41 days ago | Updated 9 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 9 hours 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
Posted 60+ days ago | Updated 9 hours ago

Medical Writer

Epis Data Inc

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Remote

Contract

Title: Medical Writer Location: Remote Duration: 12+ Months Contract Experience: 10 Years Required: The Medical Writer tasks include: The Medical Writer is a writing-based position within our Global Regulatory Affairs department. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will manage processes intended to increase project efficiency, quality, and the timely achievement
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Posted 1 hour ago