RSM’s Healthcare Regulatory recovery services are designed to identify high-impact Medicare cost report-related opportunities, including Medicare Critical Access Hospitals, PPS hospitals disproportionate share, bad debts, wage index and other related issues. Individuals selected for this role will be eligible for a discretionary bonus based on firm and individual performance.
p>Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatoryrequirements and guidances. Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
New Brighton, MN8 days ago
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. The candidate will leverage expertise in scientific, regulatory, and business considerations to ensure products developed, manufactured, or distributed comply with all applicable regulations.
Robbinsdale, MN30+ days ago
Our Maple Grove Hospital was established in 2009, is a 134-bed facility recognized as a top hospital in the state for Women and Children Care, with a Level III NICU, and is the largest Family Birth Center in the state (~5,000 deliveries per year and over 60,000 babies delivered). Our health system encompasses two hospital locations in Robbinsdale and Maple Grove as well as a network of 23 clinics which includes 13 primary clinics, 6 specialty clinics, 4 urgent care/urgency centers and emergency care offerings covering five counties.
ELK RIVER, MN30+ days ago
li>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.
Minnetonka, MN28 days ago
The Clinical Regulatory Oversight Program Manager is responsible for supporting the operational implementation, execution, and ongoing oversight of federal, state, and accreditation requirements impacting Clinical Services, including Utilization Management (UM), and Appeals and Grievances (AG) and Care Management (CM). The Program Manager partners closely with the Manager, Clinical Regulatory Oversight; Business Analysts; and cross-functional stakeholders to support regulatory implementations, audits, NCQA deliverables, and continuous compliance improvement efforts.
Golden Valley, MN8 days ago
p>Resideo is a $6.76 billion global manufacturer, developer, and distributor of technology-driven sensing and control solutions that help homeowners and businesses stay connected and in control of their comfort, security, energy use, and smart living. The project manager works with training and documentation supervisors, product managers, engineering teams, and regulatory organizations to create plans that address requirements.
Saint Louis Park, MN30+ days ago
p>Position Summary: This role is responsible for leading, coordinating, and advancing all regulatory and accreditation activities across Park Nicollet Methodist Hospital (PNMH) and its affiliated entities, including the Methodist Hospital, Melrose Institute, and Methodist Hospital homecare, hospice, home infusion, and DME programs. The scope of this role includes serving as the principal subject matter expert (SME) for TJC program manuals and other regulatory frameworks, providing leadership in policy alignment, staff education, and process improvement.
Minnetonka, MN25 days ago
Collaborate, build relationships and communicate requirements across the organization to gather reportable data, including providing business requirements to data partners (including IT and Finance Data Resource Group) and complete user acceptance testing of the resulting efforts. Experience using Axiom, Microsoft Office with Outlook, Wdesk, Wdata, SAS, SQL, Tableau, Alteryx, and Essbase knowledge considered a plus.
Minnetonka, MN30+ days ago
Exempt Status: (Yes = not eligible for overtime pay) (No = eligible for overtime pay) Yes Workplace Type: Office Our Approach to Office Workplace Type Certain positions outside our branch network may be eligible for a flexible work arrangement. Collaborate, build relationships and communicate requirements across the organization to gather reportable data, including providing business requirements to data partners (including IT and Finance Data Resource Group) and complete user acceptance testing of the resulting efforts.
Robbinsdale, Minnesota30+ days ago
Our Maple Grove Hospital was established in 2009, is a 134-bed facility recognized as a top hospital in the state for Women and Children Care, with a Level III NICU, and is the largest Family Birth Center in the state (~5,000 deliveries per year and over 60,000 babies delivered). Our health system encompasses two hospital locations in Robbinsdale and Maple Grove as well as a network of 23 clinics which includes 13 primary clinics, 6 specialty clinics, 4 urgent care/urgency centers and emergency care offerings covering five counties.
ul>Provide technical leadership and project management for oil & gas midstream permitting projects (FERC-regulated natural gas or liquids pipeline projects) and energy transition projects throughout the US. Primary Location: United States | IL | Chicago Organization: 1937 EnvSvcs-US Great Lakes East-Chicago IL Employee Status: Regular Business Justification: New Position Travel: No Schedule: Full time Job Posting: 21/04/2026 02:04:51 Req ID: 1005490.
Arden Hills, MN30+ days ago
p>The 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.
Mounds View, MN30+ days ago
This role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation.
Minneapolis, MN30+ days ago
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. 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).
Arden Hills, MN20 days ago
p>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. 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.
Mounds View, MN30+ days ago
This 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).
p>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. 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).
Minneapolis, MN5 days ago
li>Lead enterprise-wide engagement with Commercial Operations, Transmission, Integrated System Planning, Operating Companies, Legal, Regulatory, and other internal stakeholders on federal regulatory issues affecting transmission service, wholesale power transactions, organized wholesale market rules and trading strategies, generator interconnections, open access transmission policies, RTO participation, and transmission and wholesale business decisions. Provide strategic leadership and subject matter expertise on federal regulatory, wholesale market, transmission, reliability, tariff, and compliance matters before the Federal Energy Regulatory Commission (FERC), North American Electric Reliability Corporation (NERC), NERC Regional Entities, Regional Transmission Organizations (RTOs), and other regional organizations.
p>The 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.
Minneapolis, MN30+ days ago
This 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.
Minneapolis, MN7 days ago
p>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). 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.
Minneapolis, Minnesota7 days ago
p/>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.
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).
Mounds View, Minnesota6 days ago
The 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.
Eden Prairie, MN16 days ago
p>The 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.
Maple Grove, MN30+ days ago
Requisition ID: 618291 Minimum Salary: USD$215100 Maximum Salary: USD$408700 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. Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills; US-MN-Minneapolis 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.
The environment provides exposure to a wide variety of products, regulations, and cross-functional partners, and is well-suited for someone who enjoys problem-solving, structured processes, and working across teams in a professional office setting. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
Eden Prairie, MinnesotaToday
The 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.
Maple Grove, MN4 days ago
li>Must 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.
Minneapolis, MN30+ days ago
p>At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022). Located 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.
p>What 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.
Maple Grove, MN30+ days ago
p>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.