Regulatory Affairs Specialist Teleflex IncRegulatory Affairs SpecialistMaple Grove, MN$88,000–$130,000 / yearMust possess a basic understanding of product risk/benefit concepts, working knowledge of US and International regulations applicable to market authorization for Vascular products, good verbal communication, technical writing, intra- and interdepartmental communication, and collaboration skills. The pay range for this position at commencement of employment is expected to be between $88,000.00 - $130,000.00; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA) Boston Scientific CorpAssociate Director, Regulatory Affairs - Pulsed Field Ablation (PFA)Arden Hills, MNThe Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA) is responsible for leading global regulatory strategy and execution for Boston Scientific's Pulsed Field Ablation portfolio, the company's most strategically critical and fastest-growing segment within Electrophysiology. In this role, you will provide strategic regulatory leadership and serve as the primary regulatory point of contact for PFA strategy, escalations, and program-level decision-making across new products, sustaining activities, global expansion, and compliance initiatives.
NewPrincipal Regulatory Affairs Specialist Elucent MedicalPrincipal Regulatory Affairs SpecialistEden Prairie, MinnesotaThe Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post-market activities. Required: direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.
Principal Regulatory Affairs Specialist Elucent Medical IncPrincipal Regulatory Affairs SpecialistEden Prairie, MN$120,000–$135,000 / yearThe Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post-market activities. Required: direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.
NewFellow, Regulatory Affairs Boston Scientific CorpFellow, Regulatory AffairsMaple Grove, MNPartner with Regulatory Affairs leadership, integration teams, Quality, Clinical, Research and Development, Operations, Marketing and regional Regulatory Affairs teams to align regulatory strategies with business objectives and resolve issues arising from differing processes, priorities and quality systems. Prepare, review and direct regulatory submissions and health authority communications, including PMA and IDE supplements, annual reports, 30-day notices, Pre-Submissions, deficiency responses, 510(k) submissions, EU MDR and Notified Body submissions, and global registration activities, as applicable.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecMounds View, MNThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Regulatory Affairs Specialist II Stereotaxis IncRegulatory Affairs Specialist IIMinneapolis, MNPosition Summary: The Regulatory Affairs Specialist II provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information.
NewRegulatory Affairs Specialist -Neuro MedtronicRegulatory Affairs Specialist -NeuroMinneapolis, MinnesotaIf you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Advanced Regulatory Affairs Specialist Bio-TechneAdvanced Regulatory Affairs SpecialistMinneapolis, MinnesotaBy joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. This role operates with limited supervision and is responsible for ensuring compliant and efficient execution of regulatory deliverables across the product lifecycle.
NewFood Safety, Quality & Regulatory Affairs Manager Conagra Brands IncFood Safety, Quality & Regulatory Affairs ManagerMaple Grove, MN$82,000–$120,000 / yearReporting to the Director of Food Safety, Quality and Regulatory Affairs, you will lead food safety, quality, and regulatory programs at our Maple Grove, Minnesota manufacturing facility, which produces packaging for many of our popcorn brands and table spreads. When visiting these sites, the physical requirements below may apply: You may be required to walk around the facility, climb stairs/ladders, kneel, or perform repetitive tasks that require hand-eye coordination.
Regulatory Affairs Intelligence Specialist AbbottRegulatory Affairs Intelligence SpecialistSaint Paul, MinnesotaBachelors Degree (± 2 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience . This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.
Regulatory Affairs Specialist StrykerRegulatory Affairs SpecialistBloomington, MinnesotaHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Support change control activities within PLM systems, including coordinating documentation updates, routing change orders, and ensuring appropriate reviewers and approvers are assigned.
Regulatory Affairs Specialist Oxenham Group LLCRegulatory Affairs SpecialistEagan, MNThe 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.
Regulatory Affairs Specialist Patterson Companies IncRegulatory Affairs SpecialistSt Paul, MN$77,200–$100,333.33 / yearStrong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization; strong customer service-oriented skills. Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meet deadlines in timely manner.
Regulatory Affairs Specialist II - Electrophysiology (on-site) Abbott LaboratoriesRegulatory Affairs Specialist II - Electrophysiology (on-site)Plymouth, MN$61,300–$122,700 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistMN$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
International Regulatory Affairs Specialist Mclaughlin Gormley KingInternational Regulatory Affairs SpecialistBrooklyn Park, Minnesota$90,000–$100,000 / yearMGK has 100+ years' of experience focusing on sustainable & environmentally conscious ways to protect families and crops from pests around the world, using our synthetic and certified organic, botanically based pesticide products. This role requires close collaboration with sales and marketing to support compliant product strategies and effectively prioritize and manage related projects.
Regulatory Affairs Specialist Heraeus Holding GmbHRegulatory Affairs SpecialistFridley, MN$110,178–$120,000 / yearWhat We're Looking For: Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmacy, Biology, or Chemistry and 5 years of experience as a Medical Device Regulatory Affairs Specialist, Medical Device Quality Engineer, or Medical Device Design Engineer. Alternatively, Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmacy, Biology, or Chemistry 2 years of experience as a Medical Device Regulatory Affairs Specialist, Medical Device Quality Engineer, or Medical Device Design Engineer.
Regulatory Affairs Specialist -Neuro Medtronic PlcRegulatory Affairs Specialist -NeuroMinneapolis, MNThis role involves: \n\n Providing expert advice on regulatory requirements \n \n\n Preparing submissions \n \n\n Supporting approval activities \n \n\n Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations \n \n\n \nA Day In The Life \n\n Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Please note some of the above benefits may not apply to workers in Puerto Rico.\n \nFurther details are available at the link below:\n \nMedtronic benefits and compensation plans\n \nAbout Medtronic\n \nWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.\n \nOur Mission \u2014 to alleviate pain, restore health, and extend life \u2014 unites a global team of 95,000+ passionate people.
Principal Regulatory Affairs Specialist - Advertising & Promotion Boston Scientific CorpPrincipal Regulatory Affairs Specialist - Advertising & PromotionArden Hills, MNThe 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. As a key regulatory partner to the commercial organization, this role helps enable compliant and effective communications that support business objectives while protecting patients and the company.
Principal Regulatory Affairs Specialist - Advertising & Promotion (Ad Promo) Boston Scientific CorpPrincipal Regulatory Affairs Specialist - Advertising & Promotion (Ad Promo)Maple Grove, MNThe 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.
Senior Regulatory Affairs Manager MedtronicSenior Regulatory Affairs ManagerMinneapolis, MinnesotaThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find herea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Senior Regulatory Affairs Manager Medtronic PlcSenior Regulatory Affairs ManagerMinneapolis, MNThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Principal Regulatory Affairs Spec ; Pelvic Health Medtronic PlcPrincipal Regulatory Affairs Spec ; Pelvic HealthMinneapolis, MNThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Senior Regulatory Affairs Spec MedtronicSenior Regulatory Affairs SpecMounds View, MinnesotaThe Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Senior Regulatory Affairs Spec Medtronic PlcSenior Regulatory Affairs SpecMNThe Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Advanced Regulatory Affairs Specialist Bio-Techne CorpAdvanced Regulatory Affairs SpecialistMinneapolis, MN$49,700–$81,650 / yearWhy Join Bio-Techne: We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield. By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics.
Senior Regulatory Affairs Specialist - Onsite Medtronic PlcSenior Regulatory Affairs Specialist - OnsiteMinneapolis, MNThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Senior Regulatory Affairs Specialist - Onsite MedtronicSenior Regulatory Affairs Specialist - OnsiteMinneapolis, MinnesotaIf you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find herea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Regulatory Affairs Fellow - Ad Promo Boston Scientific CorpRegulatory Affairs Fellow - Ad PromoArden Hills, MNThe 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. • Minimum of 10 years experience in Regulatory Affairs or related compliance experience within the medical device industry and experience directly reviewing advertising, promotional, sales, and training materials for medical devices.
Regulatory Affairs Manager - International Compliance Operations – Structural Heart (on-site) AbbottRegulatory Affairs Manager - International Compliance Operations – Structural Heart (on-site)Saint Paul, MinnesotaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The candidate will leverage expertise in scientific, regulatory, and business considerations to ensure products developed, manufactured, or distributed comply with all applicable regulations.
NewPrincipal Regulatory Affairs Specialist: Pelvic Health MedtronicPrincipal Regulatory Affairs Specialist: Pelvic HealthMinneapolis, MinnesotaPrefer a candidate located in the Minneapolis area or who can relocate there. We are looking for a passionate Principal Regulatory Affairs Specialist with experience developing global regulatory strategies and leading worldwide Clinical Trial Applications (CTAs) for our innovative, high-risk medical device portfolio. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life.
Principal Regulatory Affairs Specialist Boston Scientific CorpPrincipal Regulatory Affairs SpecialistMaple Grove, MNThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see www.bscbenefitsconnect.comwill vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Represent the Regulatory Affairs function on cross-functional teams for new product development and sustaining activities, including manufacturing changes, site transfers and continuous improvement projects.
NewRegulatory Specialist - Rsch Pro 2-Reg Affairs University of MinnesotaRegulatory Specialist - Rsch Pro 2-Reg AffairsMinneapolis, MN$66,000–$85,000 / yearLocated at the heart of one of the nations most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. Along with study coordinators, assist with scheduling and hosting monitoring visits conducted by internal and external entities, help to resolve findings and report the visits to internal University partners.
Regulatory Affairs Specialist - Electrophysiology (on-site) Abbott LaboratoriesRegulatory Affairs Specialist - Electrophysiology (on-site)Plymouth, MN$50,700–$101,300 / yearSupports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
Regulatory Affairs Intelligence Specialist Abbott LaboratoriesRegulatory Affairs Intelligence SpecialistMN$61,300–$122,700 / yearBachelors Degree (± 2 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience. This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.
Regulatory Affairs Manager - International Compliance Operations - Structural Heart (on-site) Abbott LaboratoriesRegulatory Affairs Manager - International Compliance Operations - Structural Heart (on-site)New Brighton, MN$99,300–$198,700 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The candidate will leverage expertise in scientific, regulatory, and business considerations to ensure products developed, manufactured, or distributed comply with all applicable regulations.
Director, Clinical Affairs, Interventional (REMOTE) Teleflex IncDirector, Clinical Affairs, Interventional (REMOTE)Minneapolis, MNRemote$186,600–$279,900 / yearOur portfolio includes a broad range of clinically relevant products, such as the GuideLiner and Turnpike Catheters; the Orsiro Mission Drug-Eluting Stent; the PK Papyrus Covered Coronary Stent; the Ringer Perfusion Balloon Catheter; the Pulsar -18 T3 Self-Expanding Stent; Passeo Balloon Catheters; and the OnControl Powered Bone Access System. In coordination with the Commercial team, direct planning, execution, and reporting of the Interventional clinical education programs in North America across all four product franchises (Coronary, Structural Heart, Mechanical Circulatory Support, and Interventional Oncology) that drive safe and effective use of Teleflex Interventional products.
Leader Medical Affairs Canon USA & AffiliatesLeader Medical AffairsSaint Paul, MNRemote10 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.
Public Affairs & Public Relations Associate Director - External Communications, Tax & Accounting Wolters Kluwer N.V.Public Affairs & Public Relations Associate Director - External Communications, Tax & AccountingMinneapolis, MN$122,300–$218,550 / yearIn this role, you will serve as a trusted communications partner to the TAA divisional executive team, helping shape and deliver impactful external communications that influence key audiences, primarily media and relevant industry analysts. Create and manage a broad range of external communications materials, including press releases, holding statements, media alerts, briefings, pitches, FAQs, blogs, social media content, bylined articles, and relevant Annual Report content.
NewDirector of Assessment, Academic Affairs University of Northwestern St. PaulDirector of Assessment, Academic AffairsSaint Paul, MN$79,920–$88,800 / yearBecause our community is a significant part of our mission and the development of our students and listeners, all employees serve as ministers of the gospel of Jesus Christ by actively partnering with the University to disciple students as they grow intellectually and spiritually, and with Northwestern Media to lead people to Christ and nurture believers to maturity in their faith. Key Responsibilities: Provide strategic leadership for the university's assessment and institutional effectiveness efforts, ensuring alignment with institutional strategic planning and priorities while fostering a culture of evidence-based decision-making and continuous improvement across academic and administrative units.
NewDirector, Legal Affairs & Risk Management Center for Energy and EnvironmentDirector, Legal Affairs & Risk ManagementMinneapolis, MN$132,000–$140,000 / yearThe Director provides practical legal analysis and advice across CEE's programs and operations, ensures the organization's contracts and agreements are sound and well-managed, leads all aspects of corporate insurance and risk management, and ensures compliance with applicable laws and internal policies. Monitor and interpret developments in applicable law and regulation at the local, state, and federal levels - including executive orders, legislative changes, and agency guidance - and advise leadership on implications and recommended organizational responses.
Medical Affairs Program Manager (Remote) Coloplast CorpMedical Affairs Program Manager (Remote)Minneapolis, MNRemote$129,000–$190,000 / yearIdeal candidates will have a strong ability to translate clinical and real-world evidence into simple but relevant messages, business acumen, KOL influence skills, broad knowledge of evidence dissemination and marketing claims substantiation practices used in the medical device industry in the US. Support preparation for Coloplast meetings with government agencies, such as FDA, CMS, etc. and commercial payors by providing medical expertise, leveraging KOL networks, preparing evidence summaries and presentations.
Adraxe: Quality Affairs Lead Blackrock Neurotech LLCAdraxe: Quality Affairs LeadPlymouth, MNThis role works cross-functionally with Engineering, Clinical, and Regulatory teams, partners closely with leadership, and oversees external vendors such as CDMOs, design firms, and test labs to ensure consistent quality and regulatory alignment across the program. The impact is company-widede-risking the regulatory pathway, accelerating development timelines, and ensuring product safety and qualitydirectly supporting Adraxes mission to deliver breakthrough, minimally invasive neuromodulation therapies to patients.
Staff Global Regulatory GPO Danaher CorpStaff Global Regulatory GPOChaska, MNRemote$140,000–$170,000 / yearThe essential requirements of the job include: Bachelor's degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) with 9+ years of related work experience OR Master's degree in applicable field with 7+ years of related work experience OR Doctoral degree in applicable field with 4+ years of related work experience. The Staff Global Regulatory Affairs ensures that Beckman Coulter products, processes, and documentation adhere to global premarket regulations for registration lifecycle management, global labeling requirements and marketing material review and approval procedures.
NewProduct Regulatory Specialist Actalent IncProduct Regulatory SpecialistNew Hope, MN$39–$41 / hourThe Product Regulatory Specialist works closely with product development, supply chain, project management, marketing, and sales teams to ensure that lubricants marketed globally comply with all relevant product and chemical regulations. This role supports new product development, manages product stewardship activities, and ensures that products meet requirements related to GHS, USMCA, import/export regulations, REACH, and other regulatory frameworks.
Senior Associate General Counsel, Bank Regulatory Wells Fargo BankSenior Associate General Counsel, Bank RegulatoryMinneapolis, MinnesotaThey are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions. We provide a diversified set of banking, investment and mortgage products and services, as well as consumer and commercial finance, through our four reportable operating segments: Consumer Banking and Lending, Commercial Banking, Corporate and Investment Banking, and Wealth and Investment Management.
Director, Quality & Regulatory- Mergers & Acquisitions (M&A) PhilipsDirector, Quality & Regulatory- Mergers & Acquisitions (M&A)Plymouth, MN$181,000–$288,000 / yearEnsure successful transition and exit of transition services, including full transfer of Q&R responsibilities and retirement of TSLA obligations prior to completion of Day 2. You're the right fit if: You have a minimum of 15+ years' experience in FDA regulated global medical device environments (Class III products/devices preferred) with demonstrated experience/expertise in cross-functional Program leadership/management, focused on Quality/regulatory compliance, change management and M&A within global/matrixed medical device organizations. The Director, Quality & Regulatory M&A is an enterprise Q&R leader for M&A activities and primary interface to deal teams, providing end-to-end leadership across the transaction lifecycle, with a focus on complex divestitures, carve-outs, and separations.
NewProduct Regulatory Specialist (Hybrid) Actalent IncProduct Regulatory Specialist (Hybrid)New Hope, MN$39–$41 / hourThe Product Regulatory Specialist works closely with product development, supply chain, project management, marketing, and sales teams to ensure that lubricants marketed globally comply with all applicable regulations. This role supports product stewardship by managing regulatory documentation, validating compliance data, and assisting with global regulatory requirements related to GHS, USMCA, import/export regulations, REACH, and other regulatory frameworks.
Associate General Counsel, Regulatory and Compliance Inspire Medical Systems IncAssociate General Counsel, Regulatory and ComplianceMinneapolis, MN$235,000–$265,000 / yearReporting to the Company's General Counsel, the Senior Corporate Counsel, Regulatory and Compliance will be a key member of the legal team responsible for a broad range of legal, regulatory and compliance issues affecting the medical device industry, including FDA advertising and promotion, data privacy and protection matters, False Claims Act, Anti-Kickback Statute, OIG Pharmaceutical Compliance Guidance, the Sunshine Act, and related state regulations. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.