Senior Staff Specialist, Regulatory Affairs Apidel TechnologiesSenior Staff Specialist, Regulatory AffairsCary, ILContractorDemonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance; and distribution. Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
Life Safety Code Surveyor - Remote Essential Healthcare Solutions LLCLife Safety Code Surveyor - RemoteChicago, ILRemoteEssential HealthCare Solutions is expanding its deployment-ready bench of Life Safety and Physical Environment survey readiness consultants to support healthcare facilities — including Department of Veterans Affairs medical centers — in achieving and maintaining continuous regulatory readiness. This is an opportunity for experienced life safety and healthcare compliance professionals to apply their expertise in a flexible, project-based capacity across a growing portfolio of federal and commercial healthcare clients.
Associate Director Regulatory Affairs US & Canada Strategy Lead - Facial Aesthetics - Device AbbVie IncAssociate Director Regulatory Affairs US & Canada Strategy Lead - Facial Aesthetics - DeviceNorth Chicago, ILLeads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support. 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 thisposting based on the job grade for this position.
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.
Manager Regulatory Affairs-Chemistry Manufacturing & Controls CMC AbbVie IncManager Regulatory Affairs-Chemistry Manufacturing & Controls CMCNorth Chicago, ILRepresents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment. 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 thisposting based on the job grade for this position.
Sr. Manager, Medical Device Cyber Security Tempus AI IncSr. Manager, Medical Device Cyber SecurityChicago, IL$185,000–$215,000 / yearYou will partner closely with R&D, Product Management, Regulatory Affairs, and Quality to integrate security into the device lifecycle ("shift-left"), ensure adherence to FDA cybersecurity guidelines, and enabling Pre-Market submissions as well as Post-Market surveillance of Tempus Medical Devices. Product Security & Engineering Partnership: Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development.
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.
Clinical Research Coverage Analyst University of ChicagoClinical Research Coverage AnalystChicago, IL$65,000–$90,000 / yearAs a member of the Research Systems & Coverage Analysis (RSCA) Unit, within the Office of Clinical Research, the Coverage Analysts works as part of a team to support and optimize clinical trial initiation and financial workflows, partnering closely with research teams and key stakeholders in the process. The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.
Director, Government Affairs Regal Rexnord CorpDirector, Government AffairsRosemont, IL$150,000–$200,000 / yearThe Company's end markets benefit from meaningful secular demand tailwinds, and include factory automation, food & beverage, aerospace and defense, medical, data center, warehouse, alternative energy, residential and commercial buildings, general industrial, construction, metals and mining, and agriculture. The Company's end markets benefit from meaningful secular demand tailwinds, and include factory automation, food & beverage, aerospace, medical, data center, warehouse, alternative energy, residential and commercial buildings, general industrial, construction, metals and mining, and agriculture.
Director Foreign Trade Robert Bosch GmbHDirector Foreign TradeOakbrook Terrace, ILServing as a trusted advisor to executive leadership and key business functions-including Supply Chain, Procurement, Manufacturing, Logistics, Finance, and Legal-the Director balances regulatory requirements with business objectives, operational needs, and growth initiatives. The Director of Foreign Trade provides strategic leadership for the organization's global trade compliance and customs strategy, ensuring compliance with import and export regulations while optimizing duty costs and supporting efficient international supply chain operations.
Svp, Public Affairs AvqSvp, Public AffairsChicago, IL$1–$3 / hourMaintaining 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.
Quality Assurance Manager Compass ConsultingQuality Assurance ManagerMorton Grove, ILOur client is a global biopharmaceutical company with an Active Pharmaceutical Ingredient (API) development and manufacturing facility in the greater Chicago area. This role partners closely with T&D, Engineering, Operations, and external customers and vendors to support the full lifecycle of GxP systems.
Scientific Director Senior Medical Director Multiple Myeloma International Medical Affairs AbbVie IncScientific Director Senior Medical Director Multiple Myeloma International Medical AffairsILThe Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Senior Scientist R&D TempusSenior Scientist R&DChicago, IL$94,000–$135,000 / yearYou will rise to the challenge of designing, supporting and documenting V&V studies for molecular assays, ensure project deliverables are compliant with applicable regulations, and provide technical reports to support FDA submissions. Tempus' 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.
Director, Diagnostics Public Affairs (Public Relations) Abbott LaboratoriesDirector, Diagnostics Public Affairs (Public Relations)Lake Forest, IL$149,300–$298,700 / yearThe candidate has a proven-track record of leading integrated communications programs, top-tier media placements, developing compelling internal and external content, building thought leadership plans, managing issues and crises, and developing strategic consumer and HCP communications. This role will work in partnership with Public Affairs colleagues in regions and countries outside the U.S., support the development and execution of external public relations strategies and approaches for key product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programs.
Senior Scientist R&D Tempus AI IncSenior Scientist R&DChicago, IL$125,000–$150,000 / yearYou will rise to the challenge of designing, supporting and documenting V&V studies for molecular assays, ensure project deliverables are compliant with applicable regulations, and provide technical reports to support FDA submissions. Tempus' 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.
Senior Manager, Diagnostics Public Affairs (Public Relations) Abbott LaboratoriesSenior Manager, Diagnostics Public Affairs (Public Relations)Lake Forest, IL$129,300–$258,700 / yearThis role will also work in partnership with Public Affairs colleagues in countries outside the U.S. to support the development and execution of external public relations strategies and approaches for key product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programs. The Public Affairs senior manager for Abbott's Core Diagnostics has global responsibility for public relations, external communications activities and issues management for key priorities in the business, including Abbott and the Big Ten's We Give Blood competition.
Legal Operations Enablement Manager - Chicago, IL Archer Daniels Midland CoLegal Operations Enablement Manager - Chicago, ILChicago, IL$92,400–$151,200 / yearPreferred: Experience supporting corporate legal, compliance, or complex corporate function; familiarity with legal service intake, matter management, vendor/invoice workflows, or ticketing systems (Onit a plus); experience creating training and job aids; and interest in automation. Improve processes: Identify tasks to simplify, automate, redirect, or eliminate; redesign workflows to reduce duplication, improve turnaround; convert recurring issues into practical improvements, routing rules, self-sufficiency tools.
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.
Scientific Medical Director Global Hematology Pipeline Medical Affairs AbbVie IncScientific Medical Director Global Hematology Pipeline Medical AffairsILThe Scientific/Medical Director, Global Hematology Pipeline, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities across the hematology pipeline including disease and asset strategy, scientific differentiation, value propositions, narratives and publication strategy, evidence generation and health-care professional and provider interactions. Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate.