Adverse 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.
NewCorporate Counsel, Global Commercial Legal AbbVieCorporate Counsel, Global Commercial LegalMettawa, ILMinimum of 2 years of relevant legal experience practicing in-house at a pharmaceutical company, practicing as a member of a nationally recognized law firm in a life sciences or healthcare practice, or practicing as an attorney for a government agency, or any combination of the above. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
NewSenior Counsel, Global Commercial Legal - Oncology AbbVieSenior Counsel, Global Commercial Legal - OncologyMettawa, ILMinimum of 5+ years of relevant experience practicing in-house at a pharmaceutical company, practicing as a member of a nationally recognized law firm in a life sciences or healthcare practice, or practicing as an attorney for a government agency, or any combination of the above . Legal advice will be given on topics such as new product/indication launches, patient support models, marketing strategies, promotion, scientific exchange, regulatory submissions and managed healthcare contracting strategies.
NewDirector, Civil and Building Engineering fairlifeDirector, Civil and Building EngineeringChicago, IL$175,000–$200,000 / yearWith over $3B in annual retail sales, fairlife's portfolio of delicious, lactose-free, real dairy products includes: fairlife® ultra-filtered milk ; Core Power® High Protein Shakes, a sports nutrition drink to support post-workout recovery; fairlife® nutrition plan™ , a nutrition shake to support the journey to better health. job purpose : The Civil, Building, and Wastewater Engineering Director serves as the primary executive lead in delivering these workstreams for large-scale greenfield and brownfield dairy beverage projects typically exceeding $250M.
NewValidation Engineer Sterling Engineering Inc.Validation EngineerBuffalo Grove, IL$55–$65 / hourThe ideal candidate will have experience developing and executing IQ/OQ/PQ protocols, validating injection molding equipment and processes, troubleshooting manufacturing issues, and supporting continuous improvement initiatives in a medical device, pharmaceutical, or similarly regulated manufacturing environment. This individual will lead equipment, process, and manufacturing validations while partnering closely with Manufacturing Engineering, Quality, Operations, and Automation teams to ensure new and existing molding processes meet quality and regulatory requirements.
NewSenior Corporate Counsel CovistaSenior Corporate CounselChicago, IL$185,000–$205,000 / yearThis role supports Covista’s five Title IV higher education institutions, including institutions located in the U.S. and the Caribbean and will handle a diverse array of legal matters arising from Covista’s corporate functions and higher education institutions with a combined enrollment of 100,000 students. Works collaboratively and advises institutional departments, including student affairs, deans and registrar, to provide legal research, writing (including policy writing) and guidance on higher education-related matters, such as, student conduct, academic integrity, disability accommodations, student records and academic policy requirements.
Director US Patient Advocacy Liaison LundbeckDirector US Patient Advocacy LiaisonDeerfield, IL$240,000–$260,000 / yearCollaborate 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.
NewThought Leader Liaison (TLL), Central PharvarisThought Leader Liaison (TLL), CentralChicago, IL$170,000–$200,000 / yearBy targeting this clinically proven therapeutic target with innovative oral small molecules, the Pharvaris team is creating new alternatives to injected therapies for preventing and treating hereditary angioedema (HAE) attacks, as well as other indications related to bradykinin B2 receptor mediation. We are expanding our U.S. Commercial team and seek to establish our Thought Leader Liaison Team in the U.S. This role reports into the Head of Thought Leader Development, North America , contributing to team-wide objectives while executing locally with a high degree of autonomy and accountability.
Regulatory Affairs Specialist Sotera HealthRegulatory 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.
Senior Manager, Global CMC Regulatory Affairs Xeris PharmaceuticalsSenior Manager, Global CMC Regulatory AffairsChicago, IL$155,750–$213,600 / 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. Develop and create CMC regulatory strategy for integrated development plans and long-term planning at a cross-functional level for product(s), consistent with the corporate and project objectives.
Quality & Regulatory Affairs LancesoftQuality & Regulatory AffairsGlenview, ILRemote$18This 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.
Sr Regulatory Affairs Specialist- Medical Devices SunstarSr Regulatory Affairs Specialist- Medical DevicesSchaumburg, IllinoisWork with Regional Director, Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements. Under supervision, coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files and 510(k)’s.
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemoteChicago, ILRemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
Senior Manager, Regulatory Affairs - Nationwide Xeris PharmaceuticalsSenior Manager, Regulatory Affairs - NationwideChicago, IllinoisRemote$155,750–$213,600 / yearThe Senior Manager partners with internal stakeholders to ensure timely, high-quality regulatory submissions that comply with global health authority requirements while supporting the successful execution of development programs. Starting 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.
Senior Manager, Regulatory Affairs (MedTech) Fresenius KabiSenior Manager, Regulatory Affairs (MedTech)Lake Zurich, IllinoisThe successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment. Maintain appropriate communications within Regulatory to align on technical regulatory positions and support escalation decisions, as well as across other functions at the project team level to ensure consistent execution across affected project teams.
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.
Sr Mgr, Regulatory Affairs BaxterSr Mgr, Regulatory AffairsDeerfield, IllinoisA 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. Baxter 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.
Director of Individual Insurance Compliance & Regulatory Affairs Alera GroupDirector of Individual Insurance Compliance & Regulatory AffairsChicago, IllinoisThe ideal candidate brings deep expertise in Medicare and individual insurance compliance, strong regulatory knowledge, and experience building scalable compliance frameworks within complex, multi-site insurance or healthcare environments. This role will lead the development, implementation, and oversight of scalable compliance programs supporting Medicare Advantage, Medigap, Part D, ACA, and ancillary insurance products across a national distribution platform.
Regulatory Affairs Manager, EPA Regulated Products Central Garden & PetRegulatory Affairs Manager, EPA Regulated ProductsSchaumburg, IL$100,000–$120,000 / yearFull timeOur Innovation & Technology team is searching for a Regulatory Affairs Manager to coordinate support for the company’s regulatory projects, ensuring overall compliance with company policies and applicable EPA, state, and animal feed rules and regulations, as well as overseeing other regulatory compliance matters and initiatives related to the company and its products. Central Life Sciences (CLS) is a strategic business unit of Central Garden & Pet Company that is dedicated to delivering insect management solutions to a wide array of business-to-business markets.
Quality & 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.