65 Results for

Regulatory Affairs Jobs in Saint Paul, MN

Jobs

Maple Grove, MA17 days ago

Remote

This is a unique opportunity for biosimilars consultant professionals to leverage their regulatory expertise on biologic medical products and make a meaningful impact in the pharmaceutical and medical device industries. From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues.

Eden Prairie, Minnesota25 days ago

Bachelor’s degree in a scientific, engineering, or regulatory-related field preferred and a minimum of 5 years of experience in Regulatory Affairs/Product Compliance OR a high school diploma (or equivalent) with an equivalent combination of education, training, and experience, including at least 10 years in Regulatory Affairs/Product Compliance. Responsibilities: Participate in product development projects to define and document device classification and support the project team in defining user needs, design inputs and applicable General Safety & Performance Requirements (GSPRs).

New!

Saint Paul, MN4 days ago

Remote

Lead the client's internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities. In this consultative role, you will combine regulatory expertise, analytical rigor, and strong project leadership skills to navigate an evolving regulatory landscape while collaborating closely with clients, internal experts, and global teams.

Eagan, MN30+ days ago

The Regulatory Affairs Specialist will maintain global registrations and technical documentation, support audits, manage product compliance throughout the lifecycle, and provide strategic regulatory input to cross-functional teams. Maintain and update European technical files, including risk assessments, usability reports, and clinical evaluations.

Maple Grove, MN30+ days ago

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Review and provide regulatory feedback on advertising and promotional materials, including print, digital, web, email, social media, video, webinars, sales aids and training materials.

New!

Minneapolis, MN4 days ago

$110,000–$160,000 Per Year

The role requires strong collaboration with cross-functional partners and combines regulatory expertise, scientific knowledge, and business acumen to ensure products are developed, manufactured, and maintained in compliance with applicable global regulatory requirements. Working independently under the direction of Regulatory Affairs Management, this position owns regulatory impact assessments and develops compliant, risk-based regulatory strategies across product development and lifecycle activities.

Plymouth30+ days ago

$75,300–$150,700 Per Year

Preferred Qualifications 4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industryAdvanced level degreeClass II or Class III medical device experienceExperience with PMA supplements, 510(k) applications, and US device regulations and/or experience with EU and other international medical device regulations and submissions. Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Saint Paul, MN20 days ago

Remote

10 years’ experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting or 3 years of experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting plus 7 years of experience in healthcare industry as imaging scientist or research manager. Analyze and communicate technical and clinical product specification requirements from luminaries, market research teams, and via Medical Advisory Boards (MABs) to global business team.

New!

Minneapolis, MN4 days ago

University of Minnesota Physicians (M Physicians) is seeking a Vice President of Medical Affairs (VPMA) to provide senior physician leadership, strategic direction, and operational oversight for medical staff affairs and clinical performance across the academic medical center and its hospital-based services. Play a critical role in shaping the future of UMMC/MCH by ensuring excellence in clinical care delivery, effective medical staff governance, strong physician leadership pipelines, and alignment between institutional strategy and the missions of patient care, teaching, and discovery.

New!

Maplewood, MN2 days ago

$145,676–$178,049 Per Year

Strong project management skills and proven ability to work independently, manage multiple global projects, have a thirst for learning, and drive for tangible results in a fast-paced, cross-functional environment. Five (5) years combined experience in Product Compliance, Product Stewardship, Sustainability, Materials science, Quality, or related Regulatory Affairs role in a private, public, government or military environment.

Brooklyn Park, MN30+ days ago

This role combines regulatory interpretation with operational data management to ensure the company can accurately assess, document, and report on regulatory obligations related to topics such as PFAS chemical disclosures, carbon reporting, environmental product disclosures and supply chain environmental transparency. The role works cross-functionally with supply chain, procurement, compliance, and sustainability teams to translate complex regulatory requirements into structured data collection processes and defensible reporting.

ELK RIVER, MN30+ days ago

Full-time

Oversee the interpretation and communication of environmental and finished product testing data, guiding teams in identifying risk trends, prioritizing corrective actions, and implementing proactive interventions to safeguard product quality and food safety. This role partners closely with plant QA teams, R&D, Supply Chain, Procurement, and external stakeholders to ensure that systemic risks are identified, trends are understood, and resources are focused where they will have the greatest impact on food safety and product quality.

Saint Paul, Minnesota25 days ago

Primary responsibilities include but are not limited to the submission of new and renewal applications, student performance data to various oversight agencies, maintaining point of contact information for oversight agencies, processing employment verifications, and distribution of internal compliance updates. The company partners with workforce organizations, healthcare providers, and academic institutions to help build talent pipelines and provide pathways to career advancement, including opportunities for articulated college credit.

Plymouth, MN30+ days ago

$102,000–$149,600 Per Year

The primary purpose of this role is to manage the activities of and provide daily direction to the enterprise team of Post Market Surveillance professionals, to ensure that requirements, performance goals and improvement objectives for integer owned products are achieved. Advance Strategic Initiatives: Actively support Integer’s Manufacturing Excellence and Market-Focused Innovation strategies, ensuring Post Market Surveillance aligns with broader business goals.

Maple Grove, MA17 days ago

Remote

Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, and medical affairs, to ensure alignment on regulatory strategy and objectives. We are currently seeking talented and experienced professionals with previous experience at the FDA (Food and Drug Administration) to join our team as Former FDA Experts.

Minneapolis, MN30+ days ago

Remote

$185,000–$225,000 Per Year

Key Responsibilities: Strategic Leadership & Program Management: • Define and execute a comprehensive product security strategy that aligns with business priorities, FDA/MDR/524B expectations, and Quality Management System (QMS) requirements. • Manage the generation and maintenance of SBOMs and VEX (Vulnerability Exploitability eXchange) documents to ensure transparency and enable targeted, actionable risk management for regulators and customers.

MN30+ days ago

Provides Subject Matter Expertise and Training / development requirements and objectives for assigned areas of responsibility, specifically for appropriately evaluating returned medical device products for compliance to stated specifications and ascertaining any respective risks to patient safety. Works in close collaboration and partnership with cross functional and cross Site Global Quality Assurance stakeholders to optimize overall operational efficiency and effectiveness while maintaining and developing best in class quality systems.

Minneapolis, MN30+ days ago

Remote

Full-time

For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. The HEOL will serve as Genmab's field-based outcomes research and economic expert within our Medical Affairs function working closely with Genmab's in-house CORE team (Center for Observational Research, Real-world Evidence and Epidemiology) and the US Market Access team.

Maple Grove, MA17 days ago

Remote

Conduct signal detection activities to identify potential safety concerns associated with drug products and collaborate with cross-functional teams to mitigate risks. Support regulatory submissions and interactions with health authorities related to drug safety, including responses to safety-related inquiries and requests for information.

Maple Grove, MA17 days ago

Remote

Responsibilities: Provide expert consultation and support in bioequivalence study design, conduct, analysis, and interpretation to pharmaceutical companies and contract research organizations (CROs). Collaborate with cross-functional teams, including regulatory affairs, clinical development, and quality assurance, to ensure successful execution of bioequivalence programs.

Maple Grove, MA17 days ago

Collaborate with cross-functional teams, including manufacturing, quality assurance, quality control, regulatory affairs, and supply chain, to address GMP-related issues and drive continuous improvement initiatives. Develop, implement, and maintain GMP quality systems, including documentation control, change control, deviation management, and CAPA (Corrective and Preventive Actions).

Maple Grove, MA17 days ago

Remote

Stay abreast of emerging regulatory trends and changes affecting the medical device industry and proactively implement necessary updates to QMS processes and procedures. From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues.

Plymouth, MN30+ days ago

$149,300–$298,700 Per Year

This is a senior leadership role responsible for shaping market strategy, leading a high-performing marketing team, and partnering across the organization to accelerate growth in one of Abbott's most important therapy areas. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Saint Paul, MN30+ days ago

ABOUT Healthcare offers AI-enabled solutions to optimize patient throughput across the acute care journey from admission, through progression to discharge, aligning care transitions with clinical needs to improve patient flow and discharge efficiency with best practice workflows and actionable insights. Working with Product leadership and internal and external stakeholders, you will support the development and oversee execution of ABOUT's suite of solutions which support and enable patient transitions in their healthcare journey.

Minneapolis, MN20 days ago

In addition to core labeling engineering responsibilities, this role requires planning, coordination, and leadership of labeling implementation activities at customer sites, serving as a primary point of contact between the customer and offshore labeling teams. Job Description: We are seeking a highly skilled and detail-oriented Medical Device Labeling Engineer with experience in onsite leadership and customer coordination to support global medical device programs.

Minneapolis, MN30+ days ago

$110,000–$160,000 Per Year

Reporting to the Director of Field Marketing, the Field Communications Manager acts as the central hub for internal field-facing communication—driving alignment, improving clarity, and strengthening field readiness across the business. The Field Communications Manager is responsible for developing, managing, and optimizing all communication channels and messaging that support commercial field teams across the organization.

St. Paul, Minnesota30+ days ago

$115,000–$145,000 Per Year

Modifies procedures to meet state specific rules and regulations as well as makes necessary modifications to closely align the USON policies and procedures with the individual field group or site practice policies and procedures. Thorough, in-depth understanding of HIPAA privacy and security regulations at the national and local levels, Medicare Parts A and B, CPT 4, ICD 9, and HCPCS coding, and local carrier processes and initiatives.

Minneapolis, MN9 days ago

Remote

$185,000–$215,000 Per Year

Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.

Minneapolis, MN20 days ago

Minneapolis, MN18 days ago

Remote

$110–$110 Per Year

Qualifications: - Bachelor's degree in Computer Engineering, Computer Science, or Electrical Engineering with relevant software development experience; advanced degrees or certifications are a bonus. Key Responsibilities: - Provide technical leadership in the software/firmware product development teams with a focus on risk management, design controls, and quality assurance.

New!

Maple Grove, MN5 days ago

$50–$54.58 Per Hour

Support and lead Design History File (DHF) Remediation activities for sustaining medical device products. Perform gap assessments, evidence collection, documentation updates, and design control remediation.

Minneapolis, MN30+ days ago

Required skills include the ability to partner with business personnel at various levels of the organization, strong verbal and written communication, analytical and project management skills. This role supports the Customer Information System (CIS) Modernization Project, a large, multi‐year transformation effort rebuilding Xcel Energy's billing system and customer‐facing systems.

Minneapolis, MN30+ days ago

Remote

Full-time

Independent Thinking / Self-Initiative: Applies critical thinking to prioritize high-impact work and drive results with minimal direction; demonstrates ownership and accountability by proactively identifying solutions, securing necessary resources, and following through to achieve outcomes aligned with organizational and compliance objectives. Computer Literacy: Demonstrates advanced proficiency in a multi-system Microsoft environment and internal platforms, including the TriWest Intranet, internet-based tools, and department-specific applications; leverages technology effectively to manage workflows, ensure data accuracy, and support compliant, efficient operations.

Maple Plain, TN9 days ago

The Global Clinical Strategy Lead for Orthopedics and Robotics is responsible for developing and executing global clinical and economic evidence generation strategies to support new product introduction, expand adoption, and ensure continued regulatory approval and market access. This role works across the full product lifecycle, partnering closely with cross-functional teams including R&D, clinical operations, regulatory affairs, HEOR, medical affairs, and marketing to align evidence strategies with business and regulatory needs.

Brooklyn Park, MN30+ days ago

The role owns the disposition of nonconforming materials and devices and partners cross-functionally to investigate and resolve field issues, including CAPAs, complaints, and clinical adverse events, helping protect patients while continuously improving product and process performance. Salary (or Hourly) range for U.S locations (USD): 100,000 - 125,000 The base salary range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location.

New!

Eden Prairie, MN2 days ago

This individual will serve as the company's primary subject matter expert on coding, coverage, and payment policy — working cross-functionally with Sales, Commercial, Clinical, Regulatory, and Finance to ensure that providers and patients can access Sanuwave technologies with minimal reimbursement barriers.   . Develop and execute reimbursement strategies for new and existing medical device product lines, including coding (CPT, ICD-10, HCPCS), coverage, and payment pathway planning.

New!

Minneapolis, MN6 days ago

As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. Lead risk management for novel and existing medical devices, including risk management plans and reports, hazard analyses and use, design, and process Failure Mode & Effects Analysis (FMEA).

Afton, MN11 days ago

$200,000–$300,000 Per Year

This role is focused on sophisticated energy transactional work within the firm’s regulatory affairs practice and is well suited for an attorney with experience advising clients on complex energy infrastructure and transmission-related matters. The practice includes work involving power purchase agreements, interconnection agreements, electric service agreements, transmission service matters, large-load projects, and other industry-specific energy transactions.

Maplewood, MN30+ days ago

Remote

$250,253–$305,864 Per Year

Additional qualifications that could help you succeed even further in this role include: Experience serving as in-house counsel handling environmental matters, including regulatory compliance counseling and regulatory enforcement defense, or experience serving as an attorney for an environmental regulatory or enforcement agency. Here, you will make an impact by: Strategically managing complex environmental compliance and regulatory enforcement issues globally, including by retaining and supervising outside counsel and consultants, carefully managing budgets and coordinating with internal stakeholders.

Minneapolis, MN30+ days ago

Remote

As the worlds only end-to-end professional services firm focused on MedTech, we take clients Vision to Velocity through our comprehensive service portfolio with expertise in human-centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. Additionally, you will impact the organizations success by driving sales of company solutions and services to prospective and current clients looking for expansion opportunities, inclusive of the regulatory, preclinical, and clinical research aspects of getting a product from concept to commercialization.

Minneapolis, MN30+ days ago

Remote

Full-time

Independent Thinking / Self-Initiative: Demonstrates strong critical thinking and sound judgment to prioritize high-impact work and drive results; proactively identifies needs, solves problems, and mobilizes resources with minimal direction to achieve operational and organizational objectives. Computer Literacy: Demonstrates advanced proficiency in a multi-system environment, including Microsoft Office applications and credentialing platforms; effectively leverages internal systems, intranet resources, and industry tools to manage credentialing operations, ensure data integrity, and drive operational efficiency.

New!

Minneapolis, MN4 days ago

Remote

$190,000–$210,000 Per Year

This role sits at the intersection of strategy, sales execution, and talent development, serving as a key partner in refining our commercial strategy, strengthening our approaches, and equipping our sales organization to perform at the highest level. The Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life.

Minneapolis, MN30+ days ago

The primary objective of the Manager, Provider Education and Engagement Programs - THV is to execute Transcatheter Heart Valve’s (THV’s) vision to ensure the availability of TAVR to all patients that are in need and meet the requirements for treatment through healthcare provider education and engagement. The Manager, Provider Education and Engagement Programs - THV will support the Provider Engagement and Strategic Sales Programs Team, with an emphasis on healthcare provider educational courses, resources, tools and engagement platforms.

New!

Saint Paul, MN4 days ago

The CEO develops and implements OCHC's strategic and operational plans, maintains financial viability, leads the executive team, allocates resources, ensures compliance with regulatory bodies, acts as chief spokesperson, and is actively present in the community, building positive relationships with other community leaders, and political representatives. Financial ManagementActively supervises the business and financial affairs of the clinic and fiscal management, including accounting, budgeting, internal controls, and timely reporting.

Minneapolis, MN30+ days ago

Remote

Full-time

Technical Skills: Advanced knowledge of Microsoft Word, Excel, Project, PowerPoint, Visio, and SharePoint; Ability to function without direction to produce outcomes within timelines; Proficiency with statistical analysis, project management skills, data analysis, benchmarking, and quality improvement concepts; Collaboration skills and team-oriented approach; Presentations and meeting facilitation skills. Examples of contractually required deliverables can include, but are not limited to, monthly, quarterly, and annual performance reports on contract execution, various Quality Assurance (QA) plans, financial reporting data, medical accreditation reports, and a wide variety of other data and progress reports.

Minneapolis, MN30+ days ago

$80,000–$157,000 Per Hour

As a Relief Pharmacist, you'll enjoy the flexibility of working across multiple locations while making a real impact, supporting pharmacy teams, and connecting with a variety of patients and communities. Sales Positions Only: For sales positions that are commission-based, the above range is an estimate of total potential commission-based compensation during an associate's first year, but UNFI offers an introductory period minimum of $680 per week.

Minneapolis, MN30+ days ago

$171,700–$236,100 Per Year

This position plays a key role in supporting the Corporate Secretary's Office and the Board of Directors and related corporate governance, securities and public company matters, and ensures compliance with regulatory expectations and responsibilities of public company boards. Support Corporate Governance Processes for both holding company and subsidiaries, including: Key activities for board and committee meetings, including preparation of resolutions and board materials, as needed, and preparation and review of minutes.

New!

New Prague, MN5 days ago

Full-time

Provide quality-system and product-quality input, including hands-on technical support as needed, to Engineering, Operations, and Design Assurance on supplier issues, product changes, sustaining activities, investigations, and validation-related matters. This role supervises the Quality Engineer and Quality Technician and partners closely with Operations, Engineering, Supply Chain, Regulatory, and Quality to support compliance, product quality, and efficient execution of defined priorities.

Minneapolis, MN30+ days ago

This role also provides general, proactive, business forward legal guidance and drafting support for non-US government customer sales activities to enable innovative business models that are compliant with federal and state healthcare laws-including the False Claims Act, the Anti-Kickback Statute (AKS), data privacy and security laws, software licensing, FDA law, general commercial transaction legal principles, ASC specific regulatory frameworks, and other relevant regulations, laws, policies, practices - ensuring compliant execution of commercial and operational initiatives. The attorney will work cross functionally with a variety of enterprise and operating unit business clients, quality, regulatory, clinical, and operations teams as well as functional centers of excellence including; IP, compliance, M&A, privacy, AI, antitrust, litigation, government affairs, and health economics policy and reimbursement on issues related to compliance with healthcare-related government contracting, ASC initiatives, commercial program design, service offerings, and service and repair operational matters.

North Minneapolis, MN12 days ago

$50–$60 Per Hour

Working closely with plant management and consultants to develop appropriate messaging and responses to community concerns/questions, including documenting actions taken and closing the loop with stakeholders. This role will build and maintain structured, ongoing relationships with local community organizations, residents, and stakeholders to support the client's continued operations in Minneapolis.

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Regulatory Affairs Jobs in Saint Paul, MN

Regulatory Affairs Biosimilars Per Diem Consultant Pharmavise Corporation

Senior Regulatory Affairs Specialist- Product Development Demant

Senior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool) Parexel

Regulatory Affairs Specialist Oxenham Group LLC

Principal Regulatory Affairs Specialist - Advertising & Promotion (Ad Promo) Boston Scientific Corp

Senior Regulatory Affairs Specialist Inspire Medical Systems

Senior Regulatory Affairs Specialist - Electrophysiology (on-site) Abbott Laboratories

Leader Medical Affairs Canon USA & Affiliates

Vice President of Medical Affairs - UMMC/MCH University of Minnesota

Hardgoods Regulatory Engineering Risk and Compliance Supervisor 3M

Regulatory Sustainability Analyst Wurth Industry USA

Sr. Manager, Regulatory & Compliance JonnyPops

Compliance Coordinator Stride, Inc.

Global Manager, Post Market Surveillance Integer Holdings Corporation

Former FDA Experts Pharmavise Corporation

Director - Product Security LivaNova Plc

Manager, Post Market Surveillance Merit Medical Systems Inc

Associate Director, Health Evidence and Outcomes Liaison (HEOL) Genmab

Drug Safety Pharmaceutical Consultants Pharmavise Corporation

Bioequivalence Expert Pharmaceutical Consultant Pharmavise Corporation

GMP Professionals Pharmavise Corporation

Medical Device Quality and Compliance Experts Pharmavise Corporation

Director US Marketing- TAVI Abbott Laboratories

Product Manager About Healthcare Inc

Labeling Engineer Katalyst Healthcares & Life Sciences

Field Communications Manager Inspire Medical Systems Inc.

Healthcare Compliance Manager Minnesota Oncology

District Manager Taylor Strategy Partners

Labeling Engineer Karwell Technologies

Sr SW Quality Assurance Engineer Aminov Search Partners

Quality Engineer III Artech LLC

Compliance Analyst TechDigital Corporation

Director, Provider Network Compliance TriWest Healthcare Alliance

Clinical Strategy Specialist Artech LLC

Senior Quality Engineer CVRx Inc

Director of Medical Device Reimbursement and Market Access SANUWAVE, Inc

Sr Design Assurance Engineer Veranex Inc

Energy Attorney MB Attorney Search

Director and Assistant General Counsel, ERM, Environmental Compliance 3M

Director or Senior Director, Business Development Veranex Inc

Director, Credentialing Operations TriWest Healthcare Alliance

Director, Sales Training Zoll Medical

Manager, Provider Education and Engagement Programs-- Transcatheter Heart Valve Edwards Lifesciences

Chief Executive Officer Open Cities Health Center

Manager, Contract Deliverables TriWest Healthcare Alliance

Relief Pharmacist United Natural Foods Inc

Senior Counsel-Corporate Security Law Security Ameriprise Financial Inc

Quality Manager Electromed Inc.

Senior Principal Legal Counsel - Global Commercial & Government Contracting Medtronic Plc

Community Communications Manager The Fountain Group LLC

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