Regulatory Affairs Manager Kobayashi Healthcare International IncRegulatory Affairs ManagerNiles, ILEnsure timely submission of required reports, including Serious Adverse Event Reports (SAERs), Medical Device Reports (MDRs), and other applicable regulatory notifications. Manage and oversee adverse event reporting programs for OTC drug products, dietary supplements, cosmetics, and medical devices in accordance with FDA requirements.
Regulatory Affairs Manager, Comprehensive Cancer Center University of ChicagoRegulatory Affairs Manager, Comprehensive Cancer CenterChicago, IL$65,000–$90,000 / yearActs as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments; review of site consent forms; collection of site specific essential documents, including IRB approvals, Form FDA 1572, staff qualifications and signatures, etc. and maintenance of up-to-date regulatory files for external participating sites. The Comprehensive Cancer Center comprises over 190 faculty members from twenty departments, with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer-reviewed grants and contracts.
NewRegulatory Affairs Manager (Hybrid) ICU Medical IncRegulatory Affairs Manager (Hybrid)Lake Forest, IL$112,500–$161,250 / yearProvides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products. Establishes and manages systems and processes to support publishing of regulatory submission packages, product and facility registrations and regulatory data management.
Manager Food Safety Quality & Regulatory Affairs (Foreign Material and Operational) Conagra Brands IncManager Food Safety Quality & Regulatory Affairs (Foreign Material and Operational)Chicago, IL$109,000–$159,000 / yearWhen 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. We care about your total well-being and will support you with the following, subject to your location and role: Health: Comprehensive healthcare plans, wellness incentive program, mental wellbeing support and fitness reimbursement.
Manager, Regulatory Affairs Xeris Biopharma Holdings IncManager, Regulatory AffairsChicago, IL$120,000–$165,000 / yearStarting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable. This role will be responsible for preparing and reviewing regulatory submissions, contributing to regulatory strategy, and interacting with internal and external stakeholders to ensure compliance with global health authority requirements.
Sr Mgr, Regulatory Affairs Baxter International IncSr Mgr, Regulatory AffairsDeerfield, IL$152,000–$209,000 / yearYour role at BaxterA Senior Manager of Global Regulatory Affairs leads the development and execution of regulatory strategies to support product approvals, lifecycle management, and compliance across international markets, with deep expertise in US FDA requirements. Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
Senior Manager - Regulatory Affairs Covista IncSenior Manager - Regulatory AffairsChicago, IL$80,336.75–$145,077.09 / yearUnder the general direction of the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs is responsible for ensuring that all Covista advertising, marketing, public- and student-facing communications for all Covista institutions and business units are written in compliance with state and federal regulatory agency requirements. Due to the importance, high visibility of marketing, risks and potential impact related to misrepresentation, the incumbent must have the business acumen to accurately interpret often ambiguous regulations and partner with marketing and operations leaders to accept guidance on marketing practices.
Regulatory Affairs Specialist Sterigenics U.S.Regulatory Affairs SpecialistOak BrookWith a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. TRAINING REQUIRED: Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
Manager, Regulatory and Market Affairs Pattern Energy Group IncManager, Regulatory and Market AffairsChicago, IL$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern's existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern's engagement in regulatory and market design changes, develop Pattern's positions and execute on strategies to achieve desired objectives.
Regulatory Affairs Specialist Sotera Health CoRegulatory Affairs SpecialistOak Brook, IL$63,000–$95,000 / yearWith a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. TRAINING REQUIRED: Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
NewQuality & Regulatory Affairs inSync StaffingQuality & Regulatory AffairsGlenview, IL$20–$20.59 / hourThe Quality & Regulatory Affairs Specialist works within the global Export Regulatory and Quality team to evaluate nutrition and regulatory compliance while supporting quality operations for Kraft Heinz products worldwide. " Investigate customer and consumer quality complaints using root cause analysis, collaborating with department managers to define corrective and preventive actions (CAPA).
NewQuality & Regulatory Affairs Sunrise Systems IncQuality & Regulatory AffairsGlenview, ILThis 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. Investigates customer/consumer complaints using root cause analysis and works with department managers to determine what corrective and preventive actions are necessary.
Senior Regulatory Affairs Specialist Conagra Brands IncSenior Regulatory Affairs SpecialistChicago, IL$82,000–$120,000 / yearWe care about your total well-being and will support you with the following, subject to your location and role: Health: Comprehensive healthcare plans, wellness incentive program, mental wellbeing support and fitness reimbursement. Our focus on innovation extends beyond making great food, it also reflects our commitment to embracing new solutions that positively impact our team, the communities we serve and the health of our planet.
NewQuality & Regulatory Affairs eTeam Inc.Quality & Regulatory AffairsGlenview, IL$18–$20.58 / hourThis 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.
NewSenior 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.
Senior Associate, Regulatory Affairs (Hybrid) ICU Medical IncSenior Associate, Regulatory Affairs (Hybrid)Lake 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.
NewRegulatory Affairs Specialist Stefanini, IncRegulatory Affairs SpecialistGlenview, ILOur presence is in countries like the Americas, Europe, Africa, and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world.
NewQuality & Regulatory Affairs Apidel TechnologiesQuality & Regulatory AffairsGlenview, ILContractorThis 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. Investigates customer/consumer complaints using root cause analysis and works with department managers to determine what corrective and preventive actions are necessary.
Regulatory Affairs Director IQVIA Holdings IncRegulatory Affairs DirectorRosemont, IL$128,800–$358,800 / yearThe actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results.
NewQuality & Regulatory Affairs Axelon Services CorporationQuality & Regulatory AffairsGlenview, IL$20.59 / hourInvestigate customer/consumer complaints using root cause analysis and work with department managers to determine necessary corrective and preventive actions. Provide technical information and evaluate regulatory compliance of products while adhering to internal policies and guidelines for exporting products.
Sr Spec Regulatory Affairs Medline Industries LPSr Spec Regulatory AffairsIL$92,000–$138,000 / yearComplete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.
Senior Regulatory Affairs Specialist Medline Industries LPSenior Regulatory Affairs SpecialistIL$92,000–$138,000 / yearComplete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.
Manager, Platforms and Devices, Government Affairs and Public Policy Google LLCManager, Platforms and Devices, Government Affairs and Public PolicyChicago, ILIn this role, you will work closely with Public Relations (PR), Marketing, Legal, Partnerships, and other teams within GAPP to develop consistent public policy strategies and positions to share on Google's behalf with relevant stakeholders. Drive the development and execution of United States (US) State Policy, owning end-to-end workstreams for high-priority policy programs and advocacy campaigns across google play, android, chrome, and hardware products.
Regulatory Affairs Specialist III – Diabetes Care (on-site) AbbottRegulatory Affairs Specialist III – Diabetes Care (on-site)Buffalo Grove, IllinoisProvides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. 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.
Regulatory Affairs Specialist III - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Specialist III - Diabetes Care (on-site)Buffalo Grove, IL$68,000–$136,000 / yearProvides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. 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.
Director, Regulatory Affairs Jupiter Power LLCDirector, Regulatory AffairsChicago, IL$160,000–$180,000 / yearIn this role, you will be responsible for tracking and communicating regulatory requirements for Jupiter's entities and resources to participate in markets and will be responsible for working closely with cross-functional teams to ensure regulatory developments, project requirements, and market opportunities are effectively analyzed and communicated. Lead regulatory tracking and internal communication of requirements necessary for execution of regulatory activities supporting project development, i.e. filings for capacity market participation, interconnection processes, and other market-related requirements.
Regional Medical Affairs Manager Photocure ASARegional Medical Affairs ManagerChicago, ILPhase 4) studies Provide input into study protocols, investigator brochures, statistical analysis plans, and clinical study reports Drive study timelines, budgets, and milestones to ensure successful delivery Lead site identification, feasibility assessments, and Site Initiation Visits (SIVs) Support onboarding and training of investigators and study staff Act as primary sponsor representative for CROs and vendors Help manage vendor performance, timelines, and deliverables Contribute to the management of sponsor studies, investigator-initiated studies (IIS/IITs), research collaborations from a scientific and operational perspective Support ongoing registry programs with a focus on data quality and site performance. Key Responsibilities and Activities: External Expert Engagement: Engage/build peer-to-peer relationships with national and regional key opinion leaders (KOLs) Develop and participate in medical communication, education and training for KOLs Identify data gaps related to disease area or products based on clinical insights Participate in local and national congresses Assist in the development, implementation, and delivery of Medical Advisory Boards.
Senior Analyst - Regulatory Affairs Covista IncSenior Analyst - Regulatory AffairsChicago, IL$49,199.33–$86,253.75 / yearCovista 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. Our 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.
Technical Program Manager III, Cyber Risk Programs, Global Affairs Google LLCTechnical Program Manager III, Cyber Risk Programs, Global AffairsChicago, ILYou'll work with stakeholders to plan requirements, identify risks, manage project schedules, and communicate clearly with cross-functional partners across the company. Influence and assist business owners to close gaps in their cyber risk assessments controls and drive process adoption for sustainable security posture.
Public Policy and Government Affairs Manager, State/Local Samsara Inc.Public Policy and Government Affairs Manager, State/LocalChicago, IL$90,737.50–$137,250 / yearThe ideal candidate will enjoy serving as a key contributor on a diverse range of substantive advocacy initiatives, aid in identifying opportunities for sales enablement and engagement, developing creative strategies and content, and representing Samsara externally to key stakeholders in state and local government and allied third parties. You should apply if: You want to impact the industries that run our world: Your efforts will result in real-world impact-helping to keep the lights on, get food into grocery stores, reduce emissions, and most importantly, ensure workers return home safely.
Manager, Government Affairs Pattern Energy Group IncManager, Government AffairsChicago, IL$103,000–$138,000 / yearIntegrates input from development, operations, and commercial teams, as well as executive leadership, to identify policy-driven risks and opportunities, and to articulate the company''s positions on key issues; leads internal teams in prioritizing and analyzing the impact of critical legislative and regulatory issues based on the company's business plan; reports on key issues and impacts to relevant internal staff and executive management team. Additionally, the role will need to manage multiple initiatives at once and work closely with the development and other departments to design and execute comprehensive external affairs strategies to achieve desired policy outcomes to support the company's commericial objectives.
NewSenior Manager/Associate Director, Environmental Affairs Cypress Creek Renewables LLCSenior Manager/Associate Director, Environmental AffairsChicago, ILProvide subject matter expertise support during financing, which would include responding to Independent Engineers and external legal counsel comments, advising on contractual terms and conditions for environmental risk, and supporting internal legal, tax, and finance teams to compile environmental documentation. Directly oversee scoping and managing complex, environmental regulatory compliance processes, such as targeted environmental resource studies (e.g., wetland delineations, Phase I ESAs, cultural resource surveys), environmental permitting, and mitigation negotiation, within the Company and with outside consultants.
Sr. Manager, Medical Affairs-Global Clinical Nutrition Baxter International IncSr. Manager, Medical Affairs-Global Clinical NutritionILRemote$160,000–$220,000 / yearWhat you will be doing:Contribute to development and execution of global medical strategy aligned with product lifecycle and pipeline prioritiesPartner with R&D and upstream marketing to identify unmet clinical needs and drive product innovationProvide clinical input into early-stage development, including TPPs, endpoints, and differentiation strategySupport competitive landscape assessments and development of clinical value propositionsServe as Medical Affairs lead on global product core and exploratory/NPD teamsDeliver high-quality, evidence-based medical and scientific information to internal and external stakeholdersMaintain deep knowledge of medical literature and clinical trends to inform strategy and decision-makingLead interpretation and communication of scientific data to support alignment and engagementDevelop and support evidence generation strategies, including clinical studies, RWE, publications, and advisory forumsCollaborate cross-functionally to generate clinical and health economic evidence and translate insights into value-based outcomesBuild and maintain relationships with KOLs and contribute to scientific engagement strategies and compliant external exchangeLead regulatory input, ensure compliance, review claims, and provide training and guidance across medical, clinical, and scientific areasRepresent Global Clinical Nutrition in internal and external meetings, including scientific forums and customer interactionsLeverage data analytics, digital tools, and real-world evidence to generate actionable insightsWilling to travel up to 25% both within the US and internationally. What you will bring:Healthcare professional with 5+ years of clinical experienceLicensed clinician (PharmD, MD, RD, or other relevant allied health professional)Prior experience in Medical Affairs within pharmaceutical, biotech, or medical device industry requiredStrong understanding of regulatory and quality requirements in product development and lifecycle managementExperience in clinical research, evidence generation, and publications preferredExposure to real-world evidence, digital health, or informatics strongly preferredKnowledge of Baxter Clinical Nutrition products is preferred.
VP-Academic Affairs City Colleges of ChicagoVP-Academic AffairsChicago, ILAs the Chief Academic Officer, the Vice President provides strategic leadership for a college's instructional functions, working collaboratively with senior administrative staff to develop and implement innovative approaches to enhance academic excellence and provide students with innovative and effective learning experiences. Partners with fellow college and district leaders in development and implementation of college plans to ensure continuous and measurable improvement in student life cycle benchmarks including enrollment, academic progression, persistence, retention, completion, and post-completion success.
VP, Communications and Public Affairs Aspen GroupVP, Communications and Public AffairsChicago, IL$230,000–$290,000 / yearDrive a proactive earned media program that positions TAG and its portfolio brands - Aspen Dental, ClearChoice, WellNow, Chapter and Lovet as authoritative voices in their respective categories, unified by a common narrative of accessible, high-quality care - across national, regional, trade and digital media. TAG powers five consumer-facing brands: Aspen Dental, ClearChoice Dental Implant Centers, WellNow Urgent Care, Chapter Aesthetic Studio and LOVET Pet Healthcare each operating in highly visible, highly scrutinized healthcare categories.
Area TA Lead Director Neuroscience Intercontinental Medical Affairs AbbVie IncArea TA Lead Director Neuroscience Intercontinental Medical AffairsILDevelops and maintains professional and credible relationships with key external experts and professional societies; provides therapeutic expertise in interactions with regulators and other external groups; develops innovative research concepts for clinical data generation and communication. Will work closely with Area commercial teams to provide strategic medical input into core Neuroscience assets strategies, and to support medical/marketing activities and market access; provide scientific and technical support for assigned products.
Legal Engineering Manager, In-House (Litigation/Regulatory) Counsel AI CorpLegal Engineering Manager, In-House (Litigation/Regulatory)Chicago, IL$315,000–$385,000 / yearIn addition to managing and developing the team, you will work directly with strategic customers, help shape Harvey's go-to-market approach, and partner cross-functionally with Product, Marketing, Enablement, and Engineering to improve how Harvey serves the legal industry. Qualified lawyer with 7+ PQE, including significant experience practicing litigation, regulatory, investigations, compliance, white-collar defense, enforcement, employment litigation, financial regulatory matters, government investigations, or other contentious legal work, including experience working in-house.
Legal Engineering Manager, In-House (Litigation/Regulatory) HarveyLegal Engineering Manager, In-House (Litigation/Regulatory)Chicago, IllinoisIn addition to managing and developing the team, you will work directly with strategic customers, help shape Harvey’s go-to-market approach, and partner cross-functionally with Product, Marketing, Enablement, and Engineering to improve how Harvey serves the legal industry. Qualified lawyer with 7+ PQE, including significant experience practicing litigation, regulatory, investigations, compliance, white-collar defense, enforcement, employment litigation, financial regulatory matters, government investigations, or other contentious legal work, including experience working in-house.
Director, State Government Relations & Public Affairs Covista IncDirector, State Government Relations & Public AffairsChicago, IL$100,171.61–$181,034.70 / yearYou"ll be expected to anticipate and navigate fast-paced news, legislative and regulatory environment, build the political conditions for Covista"s strategic priorities before they"re at risk, and serve as a proactive counselor to institutional and segment leaders and other internal stakeholders needing to navigate state- and local-level decisions. 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.
Lead, State Affairs - West The Kraft Heinz CoLead, State Affairs - WestIL$141,500–$176,900 / yearDemonstrated SME depth in at least two areas relevant to KHC (e.g., food safety/labeling; agriculture and nutrition programs; packaging/EPR; tax/incentives; workforce/labor; environment/climate; privacy/data), evidenced by authored comments/testimony or task force participation. Required Experience: 8+ years in state government (legislature, governor/AG office, or state agency) or state lobbying experience Proven record drafting/negotiating legislation and regulations, delivering testimony, and securing enactments or defeating adverse proposals.
Mgr, Regulatory Labeling & Industry Engagement Nutrien LtdMgr, Regulatory Labeling & Industry EngagementChicago, IL$110,000–$120,000 / yearWhile we provide this range as general guidance, several factors are taken into consideration when making compensation decisions including, but not limited to, candidate skill set, experience and training, licensure and certifications, work location, and other business and organizational needs. This people leader role is responsible for providing effective leadership to Nutrien's Regulatory Labeling Team and overseeing strategic industry engagement, demonstrating a strong passion for industry advocacy.
Senior Manager Regulatory Strategy H. Lundbeck ASSenior Manager Regulatory StrategyDeerfield, ILRemoteManages 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.
Lead, State Affairs – Remote Hybrid within Western Region Kraft HeinzLead, State Affairs – Remote Hybrid within Western RegionChicago, IllinoisRemoteDemonstrated SME depth in at least two areas relevant to KHC (e.g., food safety/labeling; agriculture and nutrition programs; packaging/EPR; tax/incentives; workforce/labor; environment/climate; privacy/data), evidenced by authored comments/testimony or task force participation. We spark joy around mealtime with our iconic brands, including Kraft, Oscar Mayer, Heinz, Philadelphia, Lunchables, Velveeta, Planters, Maxwell House, Capri Sun, Ore-Ida, Kool-Aid, Jell-O, Primal Kitchen, and Classico, among others. .
Sr. Director, Clinical Affairs SysmexSr. Director, Clinical AffairsLincolnshire, Illinois$210,000–$330,000 / year4. Ensure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications.
Director, Clinical Affairs SysmexDirector, Clinical AffairsLincolnshire, Illinois$168,490–$264,000 / year4. Ensure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications.
Director, Clinical Affairs Sysmex America IncDirector, Clinical AffairsMundelein, IL$168,490–$264,000 / yearEnsure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications.
Sr. Director, Clinical Affairs Sysmex America IncSr. Director, Clinical AffairsIL$210,000–$330,000 / yearEnsure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications.
Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu LtdDigital Assets Regulatory Management ManagerIL$144,600–$265,100 / yearCandidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. As a Manager, you will have opportunities to: Oversee and direct end-to-end client projects focused on digital asset risk, regulatory compliance, and licensing, owning project scoping, resource allocation, timelines, quality, and deliverables.
SVP, Public Affairs AvqSVP, Public AffairsChicago, IL$215,000Maintaining a diverse staff of first-class talent (including those from BIPOC, LGBTQ communities, and others from historically underrepresented groups), and conferring a sense of value and belonging on each team member is central to our mission as expert communicators and advocates. Has experience with political, policy, or corporate advocacy communications and campaigns, including experience with brand marketing, media planning and analytics, audience targeting, integrated marketing and thought leadership strategies.
Manager, Regulatory Submissions (Remote) Tempus AIManager, Regulatory Submissions (Remote)Chicago, IllinoisRemoteTempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. Our Manager of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.