NewRegulatory Affairs Associate I # 26-15292 US Tech Solutions, Inc.Regulatory Affairs Associate I # 26-15292North Chicago, ILRecent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
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.
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.
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.
NewDirector US Regulatory Global Strategic Labelling LundbeckDirector US Regulatory Global Strategic LabellingDeerfield, IL$220,000–$250,000Partners with cross functional teams providing labeling expertise and regulatory knowledge to author and develop competitive and optimal target product labelling (TPL), CCDS, EU SmPC, USPI, CPM, Carton and Container and other labelling materials required for marketing registration that aligns with Organizational business strategy and regulatory requirements. Provides competitive labeling intelligence and insights to communicate initial labeling frameworks and regulatory expertise to address labeling challenges during development and post-approval maintenance of global labelling activities, ensuring cross functional communication and execution per process.
Regulatory Labeling Specialist Medline IndustriesRegulatory Labeling SpecialistChicago, IL$79,000–$119,000 / yearFull timeKnowledge 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. - Train and mentor new employees, divisional QA's and product managers on regulatory product structure, regulatory labeling requirements, and Medline labeling procedure(s).
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.
NewSenior Manager Regulatory Strategy LundbeckSenior Manager Regulatory StrategyDeerfield, 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.
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.
NewSenior 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).
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 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.
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.
NewMedical 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.
NewDigital Brand Experience Specialist Kimberly-ClarkDigital Brand Experience SpecialistChicago, ILRemote$116,380–$143,740 / yearFor Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world, which is why we seek to build a workforce that encompasses the experiences of our consumers. The role will collaborate with the Digital Experience Lead, internal DTS (IT) teams, and brand teams to translate consumer and business needs into a prioritized product backlog, and will support cross-functional delivery through quarterly Program Increment (PI) planning and related processes.
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.
NewSenior 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 Associate Katalyst Healthcares & Life SciencesRegulatory Affairs AssociateNorth Chicago, ILWhether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment. Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
Regulatory Affairs Associate Karwell TechnologiesRegulatory Affairs AssociateNorth Chicago, ILWhether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment. Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
NewAssociate Director International Regulatory Affairs Advertising & Promotion-Hybrid AbbVie IncAssociate Director International Regulatory Affairs Advertising & Promotion-HybridILThe Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
NewRegulatory Affairs Associate I MindlanceRegulatory Affairs Associate INorth Chicago, ILRecent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. " Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
NewRegulatory Affairs Associate I Actalent IncRegulatory Affairs Associate INorth Chicago, IL$26–$30 / hourYou will work at the intersection of Regulatory Affairs, CMC, Manufacturing, Process Development, Analytical Sciences, and other technical functions to develop submission strategies, manage timelines, coordinate cross-functional activities, and ensure the timely delivery of high-quality regulatory submissions. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Associate Director International Regulatory Affairs Advertising & Promotion AbbVie IncAssociate Director International Regulatory Affairs Advertising & PromotionILThis individual is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
NewRegulatory 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.
NewAssociate Director Regulatory Affairs Advertising & Promotion - Digital & Corporate Communications AbbVie IncAssociate Director Regulatory Affairs Advertising & Promotion - Digital & Corporate CommunicationsILApplicable 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.
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.
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 Baxter International IncAssociate Director, Regulatory AffairsDeerfield, IL$176,000–$242,000 / yearRecruitment 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. May participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc.).May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
Associate Director Regulatory Affairs Advertising & Promotion Hybrid AbbVie IncAssociate Director Regulatory Affairs Advertising & Promotion HybridILThe Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
NewRegulatory 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.
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 Specialist DEL MEDICAL IncRegulatory Affairs SpecialistBloomingdale, ILManage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. You will work cross-functionally with Engineering, Quality, Manufacturing, and Leadership teams to ensure our products meet all applicable regulatory requirements throughout the product lifecycle.
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 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.
Regulatory Affairs Senior Manager Bel SARegulatory Affairs Senior ManagerChicago, IL$145,000–$150,000 / yearAs the Senior Manager Regulatory Affairs for Bel US, you will lead regulatory affairs for Bels cheese brands, overseeing complex projects and representing the company externally within the dairy industry. Drive continuous improvement in internal policies, processes, and ways of working to enhance regulatory efficiency and effectiveness, working collaboratively as one team with other North American and global regulatory team members.
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 US Advertising and Promotion - US Specialty AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - US SpecialtyILOversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Director 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.
Director Regulatory Affairs Dairy Management Inc.Director Regulatory AffairsRosemont, IL$99,000–$120,000The Director will lead day-to-day regulatory affairs activities, working cross-functionally with regulatory, scientific, nutrition and sustainability affairs, marketing and communications, global and domestic partnerships, product research and development and nutrition research teams to ensure that dairy foods are accurately, credibly and compellingly represented in the health and wellness marketplace. Additionally, the Director will support DMI’s engagement with the broader regulatory community by monitoring policy developments, contributing technical expertise to industry discussions and collaborating with leading organizations to help ensure dairy is appropriately represented within evolving food and nutrition and regulatory frameworks.
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.
NewSenior 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.
Regulatory Affairs Specialist JBL ResourcesRegulatory Affairs SpecialistCary, ILJBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefrontoffering driven individuals the opportunity to make a meaningful impact every day.
Regulatory Affairs Specialist - Medical Device iMPact Business GroupRegulatory Affairs Specialist - Medical DeviceCary, ILEvaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposing plans or strategies for changes that do not require submissions. Evaluating the regulatory environment and contributing to internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
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.
NewSenior 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 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.
Manager, Regulatory Affairs (Hybrid - Lake Forest, IL) ICU Medical IncManager, Regulatory Affairs (Hybrid - Lake Forest, IL)Lake Forest, IL$112,500–$161,250 / yearThe Manager, Regulatory Affairs is a working Manager who assists in development and execution of Global Regulatory Strategies and Plans to assure that new products and changes to existing products are developed in line with the global registration requirements of targeted countries in support of the Consumables business. With 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.
Regulatory Affairs Specialist, North America Barry Callebaut AGRegulatory Affairs Specialist, North AmericaChicago, ILAbout the role: Barry Callebaut is a global organization poised for growth; a company which has embraced the vision to delight its customers, while out-performing its competitors, a business which is committed to sustainability, has innovation in its DNA, is a leader in complex manufacturing and supply chain solutions and is focused on being a best-in-class employer. This role partners closely with cross-functional teams-including Quality, CI&TS, Marketing, and Sales to identify regulatory risks, support product development, and maintain documentation that enables on-time product launches and compliant market access.
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.