Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerChicago, ILThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
Regulatory Affairs Specialist CollaberaRegulatory Affairs SpecialistMundelein$25–$30 / hourTemporaryContractorThe specialist will prepare and submit MDRs through the FDA eMDR portal, including completion of FDA Form 3500A and assignment of appropriate FDA codes. Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability.
Senior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteChicago, ILRemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteChicago, ILRemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
NewAssociate Dean, Academic Affairs - Nursing Chamberlain UniversityAssociate Dean, Academic Affairs - NursingDes Plaines, IL$95,000–$120,000With more than 135 years of history in healthcare education and as the largest nursing school in the country, Chamberlain University is committed to delivering a high-value education that prepares students to thrive as healthcare professionals. The College of Nursing offers a three-year Bachelor of Science in Nursing degree program and flexible post-licensure programs, such as the RN to BSN option, Master of Science in Nursing degree program, Doctor of Nursing Practice degree program and graduate certificates.
Director 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.
Senior Regulatory Labeling Specialist Medline IndustriesSenior Regulatory Labeling SpecialistNorthfield, IL$92,000–$138,000 / yearFull timeResponsible for independently supporting all aspects of the product labeling function necessary to ensure regulatory compliance for variety of product (device, drug, cosmetics, etc.) and project types (labeling, marketing materials, etc.). Comprehensive knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices, or willingness to learn through training and independent research.
NewAssociate Dean of Academic Affairs – Clinical Immersion & Experiential Learning -BSN Online Chamberlain UniversityAssociate Dean of Academic Affairs – Clinical Immersion & Experiential Learning -BSN OnlineSt. Charles, IL$70,696.34–$110,000Our College of Nursing offers a Bachelor of Science in Nursing (BSN) degree program at 23 locations and online post-licensure degree programs and certificates including RN to BSN, RN to MSN, a Master of Science in Nursing (MSN) with six Specialty Tracks, and a Doctor of Nursing Practice (DNP). This role includes direct oversight of high-impact clinical immersion experiences, leading large-scale, multi-day onsite immersions in Illinois designed to strengthen clinical competency, skills validation, and NCLEX readiness.
Senior Manager Regulatory Strategy LundbeckSenior Manager Regulatory StrategyNorthbrook, 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.
NewAssoc Regulatory - UDI Ops Medline IndustriesAssoc Regulatory - UDI OpsNorthfield, IL$67,000–$101,000 / yearFull timeWork 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.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteChicago, ILRemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
NewSpec Adverse Events Medline IndustriesSpec Adverse EventsMundelein, IL$67,000–$101,000 / yearFull timeEvaluate 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.
Senior Manager, Food Safety & Quality Compliance Treehouse FoodsSenior Manager, Food Safety & Quality ComplianceOak Brook, IL$124,800–$187,200 / yearAn employee's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, shift, travel requirements, sales or revenue-based metrics and business or organizational needs. Provide technical guidance to facility and warehouse personnel in developing systems, knowledge, and practices to ensure compliance with food safety regulations, company policies, and external audits (including customer, certification, GFSI, and regulatory).
NewQuality Systems Manager BISCO, Inc.Quality Systems ManagerSchaumburg, IL$110,000–$129,000 / yearThe ideal candidate is a practical quality leader who can manage and coach direct and indirect reports, maintain quality system discipline, analyze data and trends, and drive timely follow-through on quality issues. BISCO is seeking a Quality Systems Manager to manage and maintain BISCO’s Quality Management System and oversee key QA/QC activities in support of ISO 13485 and applicable medical device regulatory requirements.
Events Specialist CollaberaEvents SpecialistChicago$28–$30 / hourTemporaryContractor5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198) Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping Proficiency with MS Suite and complaint management systems such as SAP, TrackWise, or similar platforms Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field Mission: Support post-market surveillance and regulatory compliance efforts by reviewing product complaints, determining MDR reportability, and ensuring all adverse event submissions are completed accurately and in accordance with FDA requirements, including 21 CFR 803 and Quality System regulations.
R&D Manager, Clinical Research Medline IndustriesR&D Manager, Clinical ResearchNorthfield, IL$134,000–$201,000 / yearFull timeHiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. This role oversees internal product evaluations, clinical studies, and customer-partnered quality improvement initiatives to ensure timely, compliant, and high-quality outcomes.
MDR Specialist CollaberaMDR SpecialistMundelein$28–$30 / hourTemporaryContractorJob Title: MDR SpecialistDuration: 6 Months Contracts with possible extension/conversionLocation: Mundelein, IL 60060 (HYBRID, 3 Day Onsite and 2 Day Remote)Pay Range: $28/hr - $30/hrMust Haves: 5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry.
Medical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentChicago, IL$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
Adverse Event Specialist CollaberaAdverse Event SpecialistMundelein$25–$30 / hourTemporaryContractorJob Description: 5 years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry. Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A.
Contract Coordinator II #26-13349 US Tech Solutions, Inc.Contract Coordinator II #26-13349North Chicago, ILThis position is responsible for contract creation, negotiation, and implementation to support client initiatives to deliver consulting and/or promotional speaker services to meet critical business needs and customer expectations. Seek, develop, and establish business relationships with multiple groups across the organization including all areas of Legal, Commercial operations, medical affairs, R&D.
Associate Director/ Director, Patient Marketing - Remote Agios PharmaceuticalsAssociate Director/ Director, Patient Marketing - RemoteChicago, ILRemote$183,549–$275,324 / yearThe current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.
Associate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteChicago, ILRemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Medical Science Liaison (CNS) AtriumMedical Science Liaison (CNS)Chicago, IL$140,000–$225,000 / yearThe position centers on establishing trusted scientific partnerships, delivering high-quality scientific exchange, and generating actionable insights to guide medical strategy and clinical readiness. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title.
Senior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsChicago, ILThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
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.
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.
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.
NewRegulatory 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.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyILApplicable 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. 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 Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
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.
NewRegulatory 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.
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.
Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC AbbVie IncSenior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMCNorth Chicago, ILRepresents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies.
Regulatory Affairs Manager - Labeling Cardinal Health IncRegulatory Affairs Manager - LabelingWaukegan, ILRemote$105,100–$150,100 / yearSymbol and Mark Management: Ensure the correct application of environmental symbols and marks, including those for the WEEE Directive, battery directives (e.g., crossed-out wheeled bin), recycling (e.g., "Green Dot," Mobius loop), and packaging material identification. Risk Management: Ability to apply risk management principles (ISO 14971) to the labeling process, identifying and mitigating risks associated with labeling errors, such as product recalls, shipping holds, or regulatory enforcement actions.
NewSenior 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.
Manager Regulatory Affairs Device-Combination Products AbbVie IncManager Regulatory Affairs Device-Combination ProductsNorth Chicago, ILRepresents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. 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 Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Manager Regulatory Affairs Global Reg Strategy US & Canada AbbVie IncManager Regulatory Affairs Global Reg Strategy US & CanadaNorth Chicago, ILApplicable 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. 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 Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
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.
Manager Regulatory Affairs for Chemistry Manufacturing & Controls CMC AbbVie IncManager Regulatory Affairs for 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.
Regulatory Affairs Project Manager - Nutrition - Columbus OH/Abbott Park, IL (internal OUS) Abbott LaboratoriesRegulatory Affairs Project Manager - Nutrition - Columbus OH/Abbott Park, IL (internal OUS)IL$99,300–$198,700 / yearDepending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (market access activities, regulatory submissions/registrations; evaluation of product and/or packaging and manufacturing changes for regulatory implications; maintaining compliance documentation, review and approval of label changes, advertising and promotional items; oversight of systems related to product and/or packaging management, project management, process improvement, etc.). Supervisory/Management Responsibilities (Influence/Impact/Leadership): Provide leadership without direct authority (i.e., project leader) and provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments.
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.
Senior Director Regulatory Affairs Business Excellence AbbVie IncSenior Director Regulatory Affairs Business ExcellenceNorth Chicago, ILThe Senior Director will have a leading role in ensuring continued success of ongoing key submission support programs as well as ensuring RA business processes support future business needs, including AI enablement and knowledge management. 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 Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Director of Individual Insurance Compliance & Regulatory Affairs Alera GroupDirector of Individual Insurance Compliance & Regulatory AffairsChicago, IllinoisReporting directly to the Chief Legal Officer with a dotted-line partnership to the SVP of Strategy & Operations, this role will collaborate across Legal, Operations, Marketing, IT, Carrier Relations, and agency leadership to drive consistency, accountability, and audit readiness throughout the organization. This senior leadership role is responsible for building scalable, defensible compliance frameworks that support growth while ensuring regulatory excellence across Medicare, ACA, and ancillary insurance products.
Principal Regulatory Affairs Specialist Cardinal Health IncPrincipal Regulatory Affairs SpecialistWaukegan, IL$80,900–$127,050 / yearPay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution.
Sr. Regulatory Affairs Specialist Medline Industries LPSr. 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.
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.
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.
Associate Director, Regulatory Affairs - Advertising & Promotion Xeris Biopharma Holdings IncAssociate Director, Regulatory Affairs - Advertising & PromotionChicago, IL$174,000–$232,000 / yearSignificant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance of advertising and promotion materials. Provides leadership for and manages regulatory aspects of the copy review / approval process for promotional materials; ensures compliance of promotional materials with FDA laws, regulations, and published guidance documents.