NewQuality Lead Specialist - Regulatory Affairs GE HealthCareQuality Lead Specialist - Regulatory AffairsWaukesha, Wisconsinp style="text-align:inherit"/>
Regulatory Affairs & Quality Systems Specialist (SaMD) NeoCoil LLCRegulatory Affairs & Quality Systems Specialist (SaMD)WI$70,000–$98,000 / yearThis role provides hands-on support for U.S. FDA and international regulatory compliance, ensures the effectiveness of the Quality Management System (QMS), and supports product development and lifecycle activities in a highly regulated environment. Job Duties and Responsibilities: Supports U.S. FDA submissions, primarily 510(k), including preparation and maintenance of Design History Files (DHF), Device Master Records (DMR), and associated technical documentation.
Regulatory Affairs Specialist I WerfenRegulatory Affairs Specialist IWaukesha, Wisconsinul>Responsible to create correction and removal files, including to author field communications with appropriate management review prior to submission, to author regulatory strategies for RA Director review and signature, to interface with Werfen departments on documentation necessary to support release and to update regulatory agencies on status through closure of field actions.. Related duties include participation on design and risk management teams, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review, recall related activities, vigilance reporting and other regulatory work required to maintain worldwide compliance.
Research Regulatory Specialist - Wisconsin Institute of Neuroscience The Medical College of WisconsinResearch Regulatory Specialist - Wisconsin Institute of NeuroscienceMilwaukee, Wisconsindiv>Facilitate study start-up activities, including submissions to committees such as the Scientific Review Committee, Data Safety Monitoring Board, Institutional Biosafety Committee, or Radiation Safety Committee. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.Project Specialist - Regulatory WEC Energy Group IncProject Specialist - RegulatoryMilwaukee, WIli>Strong proficiency in Excel, Word, PowerPoint, Adobe Pro (or similar PDF creation software), SharePoint (or similar file management software), Microsoft SQL, Utilities International (UI) Modeling Platform Excel, or Audit Command Language (ACL) - or similar tools. The starting salary/pay within the pay range will be based on several factors, as applicable, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, shift, travel requirements, collective bargaining agreements, and business and organizational needs.Technical and Regulatory Specialist Veolia Environnement SATechnical and Regulatory SpecialistWIli>When needed, assist Technical Customer Advisors with creation of new direct approvals into Veolia or other 3rd party TSDFs, taking into consideration the best treatment options available as well as branch operational logistics to get the waste to the final intended TSDFs. Veolia in North America is the top-ranked environmental company in the United States for three consecutive years, and the country's largest private water operator and technology provider as well as hazardous waste and pollution treatment leader.NewSr Regulatory Affairs Engineer Harley-DavidsonSr Regulatory Affairs EngineerWauwatosa, WI$83,500–$129,300 / yearThis role will also be a critical input into the product development process by helping define project requirements and supporting the smooth delivery of the product plan by determining certification test needs and working to enable undisrupted shipment, sale & registration of product. The Sr Regulatory Affairs Engineer is responsible for developing and executing processes and activities required to certify motorcycles, systems and components in all markets in which Harley-Davidson does business.Sr Regulatory Affairs Engineer (Wauwatosa, WI, US) Harley-DavidsonSr Regulatory Affairs Engineer (Wauwatosa, WI, US)Wauwatosa, WI$83,500–$129,300 / yearThis role will also be a critical input into the product development process by helping define project requirements and supporting the smooth delivery of the product plan by determining certification test needs and working to enable undisrupted shipment, sale & registration of product. The Sr Regulatory Affairs Engineer is responsible for developing and executing processes and activities required to certify motorcycles, systems and components in all markets in which Harley-Davidson does business.Director, Regulatory Affairs & Quality Assurance Imbed Biosciences, IncDirector, Regulatory Affairs & Quality AssuranceMiddleton, WIp>The Director of Regulatory Affairs & Quality Assurance will lead global regulatory strategy and quality systems for Imbed Biosciences’s portfolio of advanced wound care products. This role is critical in advancing products through U.S. FDA pathways while expanding international market access, including achieving and maintaining CE Mark certification under EU MDR.Manager, Product Stewardship & Regulatory Affairs Johnson ControlsManager, Product Stewardship & Regulatory AffairsWisconsin$100,000–$140,000 / yeardiv>Johnson Controls International plc. The role acts as both a market‑access protector and a digital product owner for PSRA, partnering with engineering, R&D, manufacturing, supply chain, quality, legal, IT, data science, and commercial teams to embed regulatory requirements and compliance intelligence throughout the product lifecycle and enterprise workflows.
Project Specialist - Regulatory WEC Energy Group IncProject Specialist - RegulatoryMilwaukee, WIli>Strong proficiency in Excel, Word, PowerPoint, Adobe Pro (or similar PDF creation software), SharePoint (or similar file management software), Microsoft SQL, Utilities International (UI) Modeling Platform Excel, or Audit Command Language (ACL) - or similar tools. The starting salary/pay within the pay range will be based on several factors, as applicable, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, shift, travel requirements, collective bargaining agreements, and business and organizational needs.
Technical and Regulatory Specialist Veolia Environnement SATechnical and Regulatory SpecialistWIli>When needed, assist Technical Customer Advisors with creation of new direct approvals into Veolia or other 3rd party TSDFs, taking into consideration the best treatment options available as well as branch operational logistics to get the waste to the final intended TSDFs. Veolia in North America is the top-ranked environmental company in the United States for three consecutive years, and the country's largest private water operator and technology provider as well as hazardous waste and pollution treatment leader.
NewSr Regulatory Affairs Engineer Harley-DavidsonSr Regulatory Affairs EngineerWauwatosa, WI$83,500–$129,300 / yearThis role will also be a critical input into the product development process by helping define project requirements and supporting the smooth delivery of the product plan by determining certification test needs and working to enable undisrupted shipment, sale & registration of product. The Sr Regulatory Affairs Engineer is responsible for developing and executing processes and activities required to certify motorcycles, systems and components in all markets in which Harley-Davidson does business.
Sr Regulatory Affairs Engineer (Wauwatosa, WI, US) Harley-DavidsonSr Regulatory Affairs Engineer (Wauwatosa, WI, US)Wauwatosa, WI$83,500–$129,300 / yearThis role will also be a critical input into the product development process by helping define project requirements and supporting the smooth delivery of the product plan by determining certification test needs and working to enable undisrupted shipment, sale & registration of product. The Sr Regulatory Affairs Engineer is responsible for developing and executing processes and activities required to certify motorcycles, systems and components in all markets in which Harley-Davidson does business.
Director, Regulatory Affairs & Quality Assurance Imbed Biosciences, IncDirector, Regulatory Affairs & Quality AssuranceMiddleton, WIp>The Director of Regulatory Affairs & Quality Assurance will lead global regulatory strategy and quality systems for Imbed Biosciences’s portfolio of advanced wound care products. This role is critical in advancing products through U.S. FDA pathways while expanding international market access, including achieving and maintaining CE Mark certification under EU MDR.
Manager, Product Stewardship & Regulatory Affairs Johnson ControlsManager, Product Stewardship & Regulatory AffairsWisconsin$100,000–$140,000 / yeardiv>Johnson Controls International plc. The role acts as both a market‑access protector and a digital product owner for PSRA, partnering with engineering, R&D, manufacturing, supply chain, quality, legal, IT, data science, and commercial teams to embed regulatory requirements and compliance intelligence throughout the product lifecycle and enterprise workflows.
Manager, Product Stewardship & Regulatory Affairs Johnson Controls International PlcManager, Product Stewardship & Regulatory AffairsWI$100,000–$167,000 / yearThe role acts as both a market‑access protector and a digital product owner for PSRA, partnering with engineering, R&D, manufacturing, supply chain, quality, legal, IT, data science, and commercial teams to embed regulatory requirements and compliance intelligence throughout the product lifecycle and enterprise workflows. Design and deploy AI‑enabled capabilities such as: Automated global regulatory horizon scanning Intelligent SDS and material risk screening Predictive compliance risk assessment by product and market AI‑assisted customer documentation and inquiry management Ensure regulatory data governance, traceability, transparency, and audit readiness across systems.
NewSenior Manager, Global Regulatory Affairs Otsuka America PharmaceuticalSenior Manager, Global Regulatory AffairsMadison, WIp>Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
NewClinical Affairs Specimen Operations Manager Exact Sciences CorpClinical Affairs Specimen Operations ManagerMadison, WI$76,000–$125,000 / yearThe CASO Manager supports the clinical study portfolio for Exact Sciences commercial and pipeline products, collaborating with Product Core Teams and their respective working groups to successfully meet the development, evidence generation and overall strategic needs of each Exact Sciences product. Bachelor's degree in the health or life sciences, or a field as outlined in the essential duties, or Associate's degree in the health or life sciences and 2 years of experience in a field as outlined in the essential duties in lieu of Bachelor's degree, or High School Degree/General Education Diploma and 4 years of experience in a field as outlined in the essential duties in lieu of Bachelor's degree.
Director, Quality Assurance & Compliance PromegaDirector, Quality Assurance & ComplianceMadison, WisconsinExperience leading or overseeing a Quality Management System, including management review processes, governance, and executive reporting (e.g., experience in roles similar to a Management Representative or QMS lead in regulated GxP or ISO environments). Consolidated quality authority in a single accountable leader.Advisor- API/DS Network Contamination & Bioburden Control Strategy Eli Lilly and CoAdvisor- API/DS Network Contamination & Bioburden Control StrategyKenosha, WIOur current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Basic Requirements: 7+ years' experience in Pharmaceutical Manufacturing with a focus on technical support of synthesis/fermentation/cell culture and purification stages of API, Drug Substance- front line manufacturing support (clinical/commercial) development of contamination control elements for manufacturing stages/systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.Licensing Engineer EnergySolutions LLCLicensing EngineerWIp>Primarily responsible for license and regulatory compliance activities, such as preparing licensing documentation and submittals, supporting regulatory inspections, drafting regulatory position briefings, ensuring timely and adequate reporting to regulatory agencies. Represents Licensing and Regulatory Affairs on company teams, and effectively communicates activities/concerns to the Regulatory Affairs organization.Managed Services Sr. Consultant Deloitte Touche Tohmatsu LtdManaged Services Sr. ConsultantWI$120,200–$140,000 / yearLead and contribute to end-to-end delivery for Generis CARA and associated regulatory technology platforms - including requirements gathering, solution design, system configuration, content template development, and user acceptance testing. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.Global Environmental Compliance Project Engineer Rockwell Automation IncGlobal Environmental Compliance Project EngineerMequon, WIBehind our customers - amazing companies that help feed the world, provide life-saving medicine on a global scale, and focus on clean water and green mobility - our people are energized problem solvers that take pride in how the work we do changes the world for the better. You will operate at the intersection of regulatory intelligence, data engineering, and cross-functional governance-ensuring compliance with evolving environmental regulations while enabling business continuity across global product portfolios.Load moreSimilar Job SearchesRegulatory Manager JobsLaw Assistant JobsLegal Assistant JobsLegal Specialist JobsLegal Director JobsRegulatory Coordinator JobsLegal Analyst JobsRegulatory Manager JobsRegulatory Specialist JobsRegulatory Specialist JobsStand out to leading employers.Upload your resume and let employers find you for new Regulatory Specialist job openings. Plus, receive relevant job matches delivered straight to your inbox.Send Us Your ResumeCreate A Free Account
Advisor- API/DS Network Contamination & Bioburden Control Strategy Eli Lilly and CoAdvisor- API/DS Network Contamination & Bioburden Control StrategyKenosha, WIOur current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Basic Requirements: 7+ years' experience in Pharmaceutical Manufacturing with a focus on technical support of synthesis/fermentation/cell culture and purification stages of API, Drug Substance- front line manufacturing support (clinical/commercial) development of contamination control elements for manufacturing stages/systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
Licensing Engineer EnergySolutions LLCLicensing EngineerWIp>Primarily responsible for license and regulatory compliance activities, such as preparing licensing documentation and submittals, supporting regulatory inspections, drafting regulatory position briefings, ensuring timely and adequate reporting to regulatory agencies. Represents Licensing and Regulatory Affairs on company teams, and effectively communicates activities/concerns to the Regulatory Affairs organization.
Managed Services Sr. Consultant Deloitte Touche Tohmatsu LtdManaged Services Sr. ConsultantWI$120,200–$140,000 / yearLead and contribute to end-to-end delivery for Generis CARA and associated regulatory technology platforms - including requirements gathering, solution design, system configuration, content template development, and user acceptance testing. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Global Environmental Compliance Project Engineer Rockwell Automation IncGlobal Environmental Compliance Project EngineerMequon, WIBehind our customers - amazing companies that help feed the world, provide life-saving medicine on a global scale, and focus on clean water and green mobility - our people are energized problem solvers that take pride in how the work we do changes the world for the better. You will operate at the intersection of regulatory intelligence, data engineering, and cross-functional governance-ensuring compliance with evolving environmental regulations while enabling business continuity across global product portfolios.