NewSenior Analyst - Regulatory Affairs CovistaSenior Analyst - Regulatory AffairsGlenview Nas, IL$49,199.33–$86,253.75Our colleagues come from a wide range of backgrounds, business, academia, healthcare, government and nonprofits, and are part of a culture where doing exceptional work and making a meaningful difference for students and society aren't separate goals—they're one and the same. Covista is the parent company of American University of the Caribbean School of Medicine, Chamberlain University, Ross University School of Medicine, Ross University School of Veterinary Medicine and Walden University.
NewSpec Regulatory UDI Operations MedlineSpec Regulatory UDI OperationsNorthfield, IL$73,000–$110,000 / yearLeads day-to-day UDI operations by managing UDI data integrity, driving process consistency, and coordinating cross-functional efforts to ensure ongoing compliance with US FDA GUDID requirements. Strong communication and relationship-building skills; demonstrated project management, critical thinking, and problem-solving abilities to deliver results and meet deadlines.
NewDirector US Regulatory Global Strategic Labelling LundbeckDirector US Regulatory Global Strategic LabellingDeerfield, IL$220,000–$250,000Partners with cross functional teams providing labeling expertise and regulatory knowledge to author and develop competitive and optimal target product labelling (TPL), CCDS, EU SmPC, USPI, CPM, Carton and Container and other labelling materials required for marketing registration that aligns with Organizational business strategy and regulatory requirements. Provides competitive labeling intelligence and insights to communicate initial labeling frameworks and regulatory expertise to address labeling challenges during development and post-approval maintenance of global labelling activities, ensuring cross functional communication and execution per process.
Assoc Regulatory - UDI Ops MedlineAssoc Regulatory - UDI OpsNorthfield, IL$67,000–$101,000 / yearWork closely with cross-functional teams located at multiple sites to support alignment between required information for regulatory submissions and labeling & UDI database entries, and providing regulatory input to project teams as needed Assist Regulatory Affairs members and other cross-functional teams (e.g., Supply Chain, R&D, QA, Marketing, etc.,) in implementing UDI compliant solutions Support Quality Management System integration projects related to medical device labeling/ UDI compliance. Collect UDI data attributes from various sources; verify and enter UDI data into internal/external databases ensuring compliance with US FDA regulations and other regulations as needed.
Engineer, Principal Regulatory Constellation EnergyEngineer, Principal RegulatoryWarrenville, IL$152,100–$169,000Understands interrelations and functions of various organizations (e.g., Nuclear Regulatory Commission (NRC), Institute of Nuclear Power Operators (INPO), Nuclear Energy Institute (NEI), North American Electric Reliability Corporation (NERC) etc.) related to nuclear power. Perform independent and in-depth research, reviews, studies and analyses to develop, manage and implement regulatory activities, related to plant safety, reliability, maintainability, and availability ensuring compliance to site's needs, regulatory requirements, and corporate policies.
NewSenior Manager Regulatory Strategy LundbeckSenior Manager Regulatory StrategyOak Park, IL$165,000–$185,000Manages the processing of regulatory submissions with Strategy leadership and operational support; ensures submissions are prepared in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained. Working with US regulatory management and the Global Regulatory Lead, serves as US subject matter expert to support strategy development and execution for assigned products.
NewAdverse Event Specialist MedlineAdverse Event SpecialistMundelein, IL$67,000–$101,000 / yearEvaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision. Work cross‑functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.
NewManager, Transfer Pricing KPMGManager, Transfer PricingChicago, ILProgress toward the coursework and testing requirements for an approved advanced degree or an approved professional designation must be demonstrated; progress is defined as being registered for and attending classes that count towards an advanced degree; alternatively, successful completion of at least one examination for a professional designation is required; Advanced Degrees: PHD (Doctor of Philosophy), PHD (Doctor of Philosophy), PHSC (Doctor of Science Commerce), PHDE (PhD of Economics), DBA (Doctor of Business Administration), PHE (Doctor of Engineering), MBA (Masters of Business Administration), MC (Masters of Commerce), ME (Masters of Engineering), MEC (Masters of Economics) (incl Masters of International Economics from a US university), MS Economics (Master of Science Economics), MA Economics (Master of Arts Economics), MS Finance (Master of Science Finance), MA Finance (Master of Arts Finance), MA Law and Diplomacy (Master of Arts, Law and Diplomacy), MS Political Science (Master of Science Political Science), MTX (Masters of Taxation), MIAFF (Masters of International Affairs), MPP (Masters in Public Policy), JD (Juris Doctor) MIDS (Masters in Information and Data Science), MACC (Master of Accounting); Professional Designations: CPA, CFA, EA or Transfer Pricing Certificate from CIOT (Chartered Institute of Taxation), in addition to others on KPMG's approved credential listing; any individual who does not possess at least one of the approved designations/credentials when their employment commences, has one year from their date of hire to obtain at least one of the approved designations/credentials; should you like to see the complete list of currently approved designations/credentials for the hiring practice/service line, your recruiter can provide you with that list. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation.
Director US Patient Advocacy Liaison LundbeckDirector US Patient Advocacy LiaisonDeerfield, IL$240,000–$260,000Collaborate effectively with Corporate Affairs, Medical Affairs, HEOR, Commercial, Market Access, Clinical Development, and other internal stakeholders to align patient engagement activities with enterprise priorities and to ensure patient perspectives are incorporated into planning processes and organizational initiatives. Partnering cross-functionally with Corporate Affairs, Medical Affairs, Commercial, Market Access, Clinical Development, HEOR, and other stakeholders, the Director serves as a trusted advisor on patient advocacy, stakeholder engagement, and emerging patient needs.
Senior Medical Science Liaison Rare Epilepsies- North Central LundbeckSenior Medical Science Liaison Rare Epilepsies- North CentralChicago, IL$180,000–$220,000Strategic Scientific Engagement & Insight Generation: Establishes and sustains deep, longitudinal scientific partnerships with Key Opinion Leaders (KOLs), Centers of Excellence, and investigators working in rare epilepsies. This role serves as a strategic pre-launch scientific partner to external experts and internal stakeholders, generating high-quality, actionable insights that inform evidence strategy, disease education, portfolio decision-making, and launch readiness.
["Open Rank Regulatory Affairs Coordinator (RAC) (Entry - Senior)","Open Rank Regulatory Affairs Coordinator (RAC) (Entry - Senior)"] University of Colorado["Open Rank Regulatory Affairs Coordinator (RAC) (Entry - Senior)","Open Rank Regulatory Affairs Coordinator (RAC) (Entry - Senior)"]Aurora$52,860–$70,833 / yearApplication Materials Required: Cover Letter, Resume/CV, List of References: Research Services: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20164 - SOM-MED-BoneMarrow Transplant: Full-time: May 19, 2026: Ongoing Posting Contact Name: Daniel Page Posting Contact Email: daniel.page@cuanschutz.edu If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively.
Regulatory Affairs Associate Karwell TechnologiesRegulatory Affairs AssociateNorth Chicago, ILWhether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment. Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
Regulatory Affairs Associate Katalyst Healthcares & Life SciencesRegulatory Affairs AssociateNorth Chicago, ILWhether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment. Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
Director, Head of Regulatory Affairs Allstate Insurance CompanyDirector, Head of Regulatory AffairsIL$187,000–$260,000 / yearReporting to the SVP, Government & Industry Relations, the Head of Regulatory Affairs establishes enterprise regulatory governance, oversees examinations, filings, and regulatory matters, leads market conduct and remediation strategies, and develops predictive intelligence capabilities to identify emerging risks, anticipate regulatory trends, and mitigate potential business impacts before they escalate into enforcement actions or material issues. Develop and maintains a comprehensive regulatory risk dashboard that tracks complaint ratios by state, line of business, and product against industry benchmarks (NAIC complaint database), along with examination findings, MCAS trends, legislative activity heat maps, and aging of open regulatory inquiries.
["Quality & Regulatory Affairs","Quality & Regulatory Affairs"] Eteam["Quality & Regulatory Affairs","Quality & Regulatory Affairs"]GlenviewThis position requires the ability to handle complexity, work independently, and manage multiple projects under tight timelines with a strong drive for results and the ability to bring projects to completion. Investigate customer/consumer complaints using root cause analysis and work with department managers to determine what corrective and preventive actions are necessary.
Associate Director International Regulatory Affairs Advertising & Promotion-Hybrid AbbVie IncAssociate Director International Regulatory Affairs Advertising & Promotion-HybridILThe Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
["Regulatory Affairs Specialist III","Regulatory Affairs Specialist III"] Katalyst Healthcares & Life Sciences["Regulatory Affairs Specialist III","Regulatory Affairs Specialist III"]ChicagoPrepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable: 510(k) and/or De Novo submissions for FDA, technical documentation for EU MDR compliance, international product registration activities to meet business objectives, provide regulatory input to support product labeling, monitor new and changing regulatory requirements and ensure the business understands relevant impacts, lead corrective and preventive action (CAPA) efforts as assigned, provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions, assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations, support and participate in internal and external audits and regulatory agency inspections, complete QMS training activities and provide regulatory expertise to continuous improvement activities, support Lean and Kaizen initiatives, comply with all company policies and procedures, assist with any other duties as assigned. Bachelor of Science degree, 5–7 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices, current experience leading multiple successful 510(k) clearances and CE marking is required, strong understanding of medical device product life cycle and regulatory requirements, in-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR, knowledge of ISO 14971 risk management for medical devices, proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis, understanding of continuous improvement principles, strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies, strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions, high level of attention to detail and accuracy, particularly when preparing regulatory submissions.
Senior Associate, Regulatory Affairs ICU Medical IncSenior Associate, Regulatory AffairsLake Forest, IL$97,500–$139,750 / yearWith the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus allows us to bring you: Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
Associate Director International Regulatory Affairs Advertising & Promotion AbbVie IncAssociate Director International Regulatory Affairs Advertising & PromotionILThis individual is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Director Regulatory Affairs Data Standards and Governance AbbVie IncDirector Regulatory Affairs Data Standards and GovernanceNorth Chicago, ILSupport the Product Data Office initiative to establish enterprise-level data governance, improve data quality and interoperability to resolve key business challenges including Regulatory and Supply Chain data integration and Change Control processes. Builds and uses AbbVie's Data Catalogue to drive clear definitions for critical data elements, supporting data lineage verification and mapping properties across systems for interoperability of Regulatory data across the product lifecycle.