Regulatory affairs jobs in Minneapolis, MN

Remote

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Today

Primary Role: Lead document review, ensure FDA submission readiness.Compile Design History File (DHF) and Quality Management System (QMS) alignmentVerify traceability across risk analysis, verification, and validationEnsure all cybersecurity and AI documentation meets FDA s Software as a Medical Device (SaMD) guidanceCoordinate 510(k) narrative and eCopy preparationProfile: Prior 510(k) experience with AI/ML-based medical devicesFamiliarity with IEC 62304 (software lifecycle), ISO 14971 (risk

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Full-time, Third Party

Depends on Experience

Regulatory Compliance Specialist

Minneapolis, Minnesota

•

Yesterday

TITLE: Regulatory Compliance Specialist LOCATION: Plymouth, Minnesota ANTICIPATED DURATION: 6 Month Contract to Hire Synergis client, a leading veterinary health company, has engaged us in a search for a Regulatory Compliance Specialist to augment their growing team to launch a new product! The Regulatory Compliance Specialist will play a key role in making sure that the products and company processes comply with the laws, standards, and regulations that govern these new products. Regulatory

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Contract

$45 - $50

Sr. R&D Engineer

Maple Grove, Minnesota

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Today

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your

Full-time

USD 82,600.00 per year

R&D Engineer

Maple Grove, Minnesota

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Today

Full-time

USD 76,000.00 per year

R & D Engineer III - Sustaining

Maple Grove, Minnesota

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Today

Full-time

USD 76,000.00 per year

Power Generation Risk Engineering Consultant

Remote or California

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Today

Zurich is currently looking for a Senior Risk Engineering Consultant OR Risk Engineering Specialist with extensive experience in power plant operations to join the Global Energy - Power Generation team. This is a work from home role ideally within Western U.S. (Will consider any other locations within the U.S. as well) This role will include expected travel up to 50% to service accounts across the U.S.. This position is designed to help Power Generation Risk Engineering support the workload ass

Full-time

USD 98,300.00 - 185,100.00 per year

Sr. Regulatory Specialist SaMD / 510(k) / Medical Device | Contract | Remote

Remote

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9d ago

Sr. Regulatory Specialist SaMD / 510(k) / Medical Device Location: Remote - (Philadelphia, PA must work in EST time zone) Duration: Long Term Contract About the Role:We are seeking a Senior Regulatory Specialist with deep expertise in Software as a Medical Device (SaMD) and 510(k) submissions to support regulatory strategy and compliance for next-generation digital health and AI-enabled medical products.This role will partner closely with cross-functional teams (R&D, Quality, and Clinical) to en

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Contract

Depends on Experience

Project Manager, Med Device, R&D PMO, Design Changes

Remote or Almont, Colorado

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Today

Description: Our Fortune 500 Medical Device client is seeking a Project Manager to lead a high-visibility cost reduction initiative within the R&D PMO. This initiative is part of an enterprise-wide effort focused on driving product cost savings through design modifications and component exchange programs while navigating a complex, global matrix organization. The project has completed feasibility and scoping phases and now requires a strong PM to lead the implementation and delivery phase. We

Contract

USD 80.00 - 90.00 per hour

LVD Remote Support Engineer

Remote or Mequon, Wisconsin

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Today

Rockwell Automation is a global technology leader focused on helping the world's manufacturers be more productive, sustainable, and agile. With more than 28,000 employees who make the world better every day, we know we have something special. Behind our customers - amazing companies that help feed the world, provide life-saving medicine on a global scale, and focus on clean water and green mobility - our people are energized problem solvers that take pride in how the work we do changes the world

Full-time

Scientist 3 - Clinical Research

Remote or Hopewell Township, New Jersey

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Today

Title: Scientist 3 - Clinical Research - Location: TITUSVILLE / NJ / 08560 Duration: 5 months (possible for extensions) (REMOTE Position Job Description: Senior Scientist Clinical Research Responsible for the translation and implementation of (non-medical) scientific concepts into the study design and/or program across planning, execution, and reporting, including integration of biomarkers, digital technologies, data science initiatives, and select vendors Job Responsibilities Program/Tria

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Third Party, Contract

$Market

Senior Engineer, Industrialization Design

Remote or Twinsburg, Ohio

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Today

Full-time

Junior Full Spectrum Cyber AI Researcher

Remote

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Today

The Leidos Cyber Accelerator is redefining how we build, validate, and scale next-generation cyber and artificial intelligence (AI) capabilities. We are seeking a Research Scientist who thrives at the intersection of cybersecurity, AI and agentic AI, and mission-aligned engineering. The ideal candidate is passionate about a broad range of projects from research & development to prototype development, culminating in deployment of our products to customers. In this role you will design, prototype,

Full-time

USD 55,250.00 - 99,875.00 per year

Mid and Senior Full Spectrum Cyber AI Researcher

Remote

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Today

Full-time

USD 85,150.00 - 153,925.00 per year

Associate Director, R&D Data Science & Digital Health - Oncology/Prostate Cancer

Remote or Pennsylvania

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Today

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

Full-time

USD 137,000.00 - 235,750.00 per year

Senior Product Security Engineer

Remote or Mayfield Heights, Ohio

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Today

Full-time

Assistant Facilitator - Value Engineering

Remote or Boston, Massachusetts

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Today

This position is located near Nashville, TN. Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together. Role description: Arcadis is looking to hire a few

Full-time

USD 68,182.00 - 129,385.00 per year

Senior Principal Systems Safety Engineer (Hybrid)

Remote or Cedar Rapids, Iowa

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Today

Date Posted: 2025-08-22 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, an RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and

Full-time

USD 124,000.00 per year

Principal Software Design Quality Engineer

Maple Grove, Minnesota

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Today

Full-time

USD 99,100.00 per year

Veeva RIM Submission BSA

Remote

•

Yesterday

Business Analyst with 7+ years of experience in biotech industry. Candidate will be a subject matter expert in Veeva RIM Submission module. Specifically, around Data Analysis, Data Cleansing and have extensive Integration experience. Knowledge of Veeva Rim Registration Module is a plus. Submissions/Registration module and ideally Active Dossier experience Job Description: Requirements Gathering:Work closely with stakeholders, including regulatory affairs, IT, and compliance teams, to understand

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Contract

Depends on Experience

Veeva RIMS Analyst

Remote

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13d ago

Role: Veeva RIM Submission BSA Location: Remote or onsite in Foster City, CA Length: Long term rolling contract Business Analyst with 7+ years of experience in biotech industry. Candidate will be a subject matter expert in Veeva RIM Submission module. Specifically, around Data Analysis, Data Cleansing and have extensive Integration experience. Knowledge of Veeva Rim Registration Module is a plus. Submissions/Registration module and ideally Active Dossier experience Job Description: Requirements

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Contract

$60 - $65

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Regulatory affairs jobs in Minneapolis, MN, USA