Product Support Regulatory Affairs Specialist MedlineProduct Support Regulatory Affairs SpecialistNorthfield, IL$23.25–$33.75 / hourAt least one year of customer service and product research experience with an ability to manage workloads that allow for product-specific analytics to occur for departmental process improvement(s). Analyze manufacturer websites and other medical databases to research regulatory requirements for newly created items to ensure Medline databases are accurate and complete.
NewSVP Quality Systems MedlineSVP Quality SystemsNorthfield, IL$309,000–$464,000 / yearThe role establishes functional strategy, governance, performance expectations, and organizational capability while partnering across Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership as relevant to the function. Provide enterprise leadership for the global Quality Management System and its core processes, including post-market surveillance and quality technology, to ensure compliant, harmonized, data-enabled, and sustainable quality operations.
NewSustaining Quality Director MedlineSustaining Quality DirectorNorthfield, IL$177,000–$266,000 / yearHiring staff, recommending pay increases, performing performance reviews, training and developing staff, estimating personnel needs, assigning work, meeting completion dates, and ensuring consistent application of organizational policies. At least 7 years of experience in medical device, pharmaceutical, drug combination product, or another regulated industry, including experience with quality systems, design controls, risk management, CAPA, remediation, or post-market quality activities.
NewDir Quality Technology MedlineDir Quality TechnologyNorthfield, IL$203,000–$305,000 / yearLead selection, implementation, and rollout of quality systems, including requirements definition, vendor evaluation, business case development, configuration, data migration, and user adoption, ensuring systems are validated and maintained in a GxP compliant state. The Director, Quality Technology leads the strategy, roadmap, and execution of technology solutions that support Quality Assurance and Regulatory Affairs (QARA).
NewVP Distribution Quality MedlineVP Distribution QualityNorthfield, IL$234,000–$351,000 / yearThe role establishes functional strategy, governance, performance expectations, and organizational capability while partnering across Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership as relevant to the function. Provide executive leadership for distribution and commercial quality, ensuring product integrity, compliant storage and transportation, effective hold controls, and consistent quality oversight from manufacturing release through final delivery to customers.
Regulatory Affairs Associate Katalyst HealthCares & Life Sciences IncRegulatory Affairs AssociateNorth Chicago, ILThis role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.
Regulatory Affairs Associate Katalyst Healthcares & Life SciencesRegulatory Affairs AssociateNorth Chicago, ILThis role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.
Senior Analyst, Regulatory Affairs Covista IncSenior Analyst, Regulatory AffairsChicago, IL$49,199.33–$86,253.75 / yearOur colleagues come from a wide range of backgrounds, business, academia, healthcare, government and nonprofits, and are part of a culture where doing exceptional work and making a meaningful difference for students and society aren"t separate goals-they"re one and the same. Specializing in Federal Student Aid programs and Veterans Benefits, the Senior Regulatory Affairs Analyst is responsible for interpreting statutes, regulations and administrative rules of various issuing bodies and developing procedures and processes to assure compliance with those rules and monitoring the performance of those procedures and processes.
NewRegulatory Affairs Associate II The Fountain Group LLCRegulatory Affairs Associate IINorth Chicago, IL$40–$43 / hourAuthor and submit FDA PMA supplements, including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports. Prepare and submit regulatory applications, amendments, renewals, annual reports, supplements, and variations for regulated products.
NewAssociate Regulatory Affairs Quality, Standards & Training Director (Global Patient Safety ) Exelixis IncAssociate Regulatory Affairs Quality, Standards & Training Director (Global Patient Safety )IL$163,000–$231,000 / yearCollaborate with Quality Assurance and cross-functional stakeholders to support health authority inspections across GPS and Regulatory Affairs ensuring the RA function remains in a continuous state of inspection readiness. Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs related documents.
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.
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.
Senior Manager - Regulatory Affairs Covista IncSenior Manager - Regulatory AffairsChicago, IL$85,000–$120,000 / yearUnder the general direction of the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs serves as a regulatory advisor responsible for translating complex regulatory, legislative, accreditation, and policy developments into practical business guidance, implementation strategies, and operational guardrails across Covista institutions and business units. The role collaborates with institutional and functional leaders to identify regulatory implications, develop practical and compliant solutions, promote consistent decision-making, and support regulatory readiness across Covista institutions.
NewSenior Manager, Global Scientific & Regulatory Affairs (SRA) Center of Excellence (CoE) MarsSenior Manager, Global Scientific & Regulatory Affairs (SRA) Center of Excellence (CoE)Chicago, IllinoisPre-Regulatory" Intelligence Frameworks: Design and govern the organizational frameworks, processes and channels required to systematically capture "pre-regulatory" insights (such as emerging scientific trends, shifts in government risk assessment endpoints, and novel methodologies) from internal technical subject matter experts and regional teams. By collaborating with an expansive, matrixed network of senior business leaders, technical subject matter experts and regional SRA teams, the Senior Manager designs robust frameworks that integrate seamlessly within enterprise level risk management systems to assess financial and operational impacts.
NewSenior Manager, Global Scientific & Regulatory Affairs (Sra) Center Of Excellence (Coe) MarsSenior Manager, Global Scientific & Regulatory Affairs (Sra) Center Of Excellence (Coe)Chicago, ILPre-Regulatory" Intelligence Frameworks: Design and govern the organizational frameworks, processes and channels required to systematically capture "pre-regulatory" insights (such as emerging scientific trends, shifts in government risk assessment endpoints, and novel methodologies) from internal technical subject matter experts and regional teams. By collaborating with an expansive, matrixed network of senior business leaders, technical subject matter experts and regional SRA teams, the Senior Manager designs robust frameworks that integrate seamlessly within enterprise level risk management systems to assess financial and operational impacts.
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.
NewRegulatory Affairs Associate II MindlanceRegulatory Affairs Associate IINorth 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. Job deliverables will include: - Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
Associate 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.
Senior Associate, Regulatory Affairs (Hybrid - Lake Forest, IL) ICU Medical Inc.Senior Associate, Regulatory Affairs (Hybrid - Lake Forest, IL)Lake Forest, ILWith 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. Provides regulatory support and expertise associated with global and US registration of device electro mechanical products, including in-depth analysis of the requirements and tracking of deliverables.
Director Regulatory Affairs Data Standards and Governance AbbVie IncDirector Regulatory Affairs Data Standards and GovernanceNorth Chicago, ILSupport the Product Data Office initiative to establish enterprise-level data governance, improve data quality and interoperability to resolve key business challenges including Regulatory and Supply Chain data integration and Change Control processes. Builds and uses AbbVie's Data Catalogue to drive clear definitions for critical data elements, supporting data lineage verification and mapping properties across systems for interoperability of Regulatory data across the product lifecycle.