297 Results for

Regulatory Affairs Jobs in Waukegan, IL

Jobs

Mundelein11 days ago

$25–$30 Per Hour
Temporary
Contractor

The 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.

Mundelein11 days ago

$28–$30 Per Hour
Temporary
Contractor

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. Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths.

Mundelein12 days ago

$28–$30 Per Hour
Temporary
Contractor

Job 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.

Mundelein12 days ago

$25–$30 Per Hour
Temporary
Contractor

Job 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.

North Chicago, IL14 days ago

li> Whether 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.

Responsibilities:

Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU.

North Chicago, IL14 days ago

Responsibilities:

Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU.

Waukegan, IL20 days ago

$80,900–$127,050 Per Year

Pay 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.

New!

Waukegan, IL4 days ago

Remote

$66,500–$88,020 Per Year

This could include support of change development projects, new product development, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. Pay 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.

New!

North Chicago, IL, IL1 day ago

$28–$30 Per Hour

li>Recent 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 Description:

Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.

New!

North Chicago, IL1 day ago

Recent 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.

Lake Forest, IL12 days ago

$97,500–$139,750 Per Year

p>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.

Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.

North Chicago, IL18 days ago

With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. Responsibilities: Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.

New!

North Chicago, IL4 days ago

Responsibilities:

Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.

IL30+ days ago

This 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.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

North Chicago, IL18 days ago

With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. Responsibilities: Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.

North Chicago, IL30+ days ago

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. 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.

Deerfield, IL30+ days ago

$176,000–$242,000 Per Year

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. 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.

IL26 days ago

The 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.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

New!

North Chicago, IL3 days ago

p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

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.

Libertyville, IL30+ days ago

$130,000–$185,000 Per Year

Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.

IL18 days ago

li>Oversees 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.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

IL13 days ago

p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

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.

Rosemont, IL30+ days ago

$99,000–$120,000

p>The 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.

National Dairy Council (NDC), the non-profit organization founded by dairy farmers and funded by the national dairy checkoff program, has been committed to research-based nutrition education and communications since its start in 1915.

Cary, IL10 days ago

Evaluating 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.

North Chicago, IL30+ days ago

Lake Forest, IL17 days ago

$112,500–$161,250 Per Year

p>The 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.

North Chicago, IL30+ days ago

li>Represents 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.

Waukegan, IL30+ days ago

Remote

$68,500–$88,020 Per Year

Collaborate with internal Cardinal regional regulatory partners on new and modified product development projects, to establish and integrate international regulatory strategy into project activities and ensure timely execution. Maintain regulatory data, intelligence, and analytics through use of CAH regulatory information management systems, including trend analysis of critical regulatory submission related activities, and generate needed reports.

Cary, IL20 days ago

JBL 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.

New!

Deerfield, IL3 days ago

$152,000–$209,000 Per Year

Your 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.

IL12 days ago

$92,000–$138,000 Per Year

li>

Complete 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.

IL30+ days ago

$92,000–$138,000 Per Year

IL30+ days ago

$92,000–$138,000 Per Year

New!

IL5 days ago

$99,300–$198,700 Per Year

li>

Depending 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.

North Chicago, IL30+ days ago

The Director Regulatory Affairs, Device is responsible for combining knowledge of scientific, regulatory and business issues to support and drive strategy for regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations. 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.

Des Plaines, IL30+ days ago

$38–$43 Per Hour

In this role, you won't just maintain compliance-you'll drive registrations, build and manage dossiers, interface with agencies, and influence regulatory strategy across products that support animal health, food safety, and global dairy production. 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.

Buffalo Grove, IL30+ days ago

$68,000–$136,000 Per Year

li>Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Buffalo Grove, Illinois30+ days ago

li>Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

North Chicago, IL30+ days ago

li>Represents 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.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

IL24 days ago

$78,000–$156,000 Per Year

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Cary, Illinois8 days ago

$55–$64.45 Per Hour

p>* Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions. The complexity implied at this level of problem solving relates to the ability to filter, prioritize, analyze and validate potentially complex and dynamic material.

Cary, IL12 days ago

Contractor

Demonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance; and distribution. Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.

North Chicago, IL30+ days ago

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

Vernon Hills, Illinois30+ days ago

li>

In partnership with Medical Safety leadership, oversee medical safety and risk management for the Vascular portfolio, ensuring compliance with global regulatory requirements (e.g., FDA, PMDA, Notified Bodies, GLPs) and providing clinical expertise for adverse event assessment, post‑market surveillance, risk management planning, safety communications, and Field Action Committee activities.

Engage early and continuously with cross‑functional partners, including Marketing, Regulatory, R&D, Clinical Affairs, Quality, Business Development, Scientific Affairs, Physician Training, and Global Medical Affairs Regions to align medical strategy with program and platform objectives.

IL30+ days ago

p>The Associate Scientific Director, Dermatology - US Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities).

Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.

IL30+ days ago

p>The Associate Scientific Director/Scientific Director, Dermatology - US Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities).

IL30+ days ago

$181,400–$326,500 Per Year

li>In partnership with Medical Safety leadership, oversee medical safety and risk management for the Vascular portfolio, ensuring compliance with global regulatory requirements (e.g., FDA, PMDA, Notified Bodies, GLPs) and providing clinical expertise for adverse event assessment, post‑market surveillance, risk management planning, safety communications, and Field Action Committee activities.

Lake Zurich, IL30+ days ago

$185,000–$220,000 Per Year

p>The Director, Medical Affairs will lead the field clinical education team and ensure that the respective territory engagement plans are effectively executed per defined targets, following Fresenius Kabi compliance rules and code of conduct and that relevant medical and scientific insight is routinely shared to optimize the Medical Affairs strategy for the nutrition portfolio.

3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens.

Mettawa, IL30+ days ago

Provides scientific and technical support for assigned multiple myeloma products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned multiple myeloma products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).

IL30+ days ago

li>

Translate regulatory insights into GIR strategy artifacts-including state risk heat maps, issue‑specific playbooks (e.g., claims practices, underwriting/rating transparency, consumer notices), and executive readouts that guide advocacy prioritization and regulator engagement.

Organizational Leadership & Talent Development: Leads, develops, and scales high‑performing teams; establishes clear accountability, succession planning, and leadership bench strength.

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Regulatory Affairs Jobs in Waukegan, IL

Regulatory Affairs Specialist Collabera

Events Specialist Collabera

MDR Specialist Collabera

Adverse Event Specialist Collabera

Regulatory Affairs Associate Katalyst Healthcares & Life Sciences

Regulatory Affairs Associate Karwell Technologies

Principal Regulatory Affairs Specialist Cardinal Health Inc

Sr Regulatory Affairs Specialist Cardinal Health Inc

Regulatory Affairs Associate I # 26-15292 US Tech Solutions, Inc.

Regulatory Affairs Associate I Mindlance

Senior Associate, Regulatory Affairs (Hybrid) ICU Medical Inc

Senior Associate Regulatory Affairs Submission Management AbbVie Inc

Senior Associate Regulatory Affairs Submission Management Hybrid AbbVie Inc

Associate Director International Regulatory Affairs Advertising & Promotion AbbVie Inc

Associate Regulatory Affairs Submission Management Hybrid AbbVie Inc

Manager Regulatory Affairs Global Reg Strategy US & Canada AbbVie Inc

Associate Director, Regulatory Affairs Baxter International Inc

Associate Director Regulatory Affairs Advertising & Promotion Hybrid AbbVie Inc

Senior Manager Regulatory Affairs Global Reg Strategy US & Canada - Immunology AbbVie Inc

Regulatory Affairs Manager Hollister Inc

Senior Manager Regulatory Affairs US Advertising and Promotion - US Specialty AbbVie Inc

Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie Inc

Director Regulatory Affairs Dairy Management Inc.

Regulatory Affairs Specialist - Medical Device iMPact Business Group

Manager - Device Regulatory Affairs Submission Management Hybrid AbbVie Inc

Manager, Regulatory Affairs (Hybrid - Lake Forest, IL) ICU Medical Inc

Manager Regulatory Affairs Device-Combination Products AbbVie Inc

Sr. Regulatory Affairs Specialist Cardinal Health Inc

Regulatory Affairs Specialist JBL Resources

Sr Mgr, Regulatory Affairs Baxter International Inc

Senior Regulatory Affairs Specialist Medline Industries LP

Sr. Regulatory Affairs Specialist Medline Industries LP

Sr Spec Regulatory Affairs Medline Industries LP

Regulatory Affairs Project Manager - Nutrition - Columbus OH/Abbott Park, IL (internal OUS) Abbott Laboratories

Director Regulatory Affairs Devices and Combination Products AbbVie Inc

Regulatory Affairs Specialist Actalent Inc

Regulatory Affairs Specialist III - Diabetes Care (on-site) Abbott Laboratories

Regulatory Affairs Specialist III – Diabetes Care (on-site) Abbott

Manager Regulatory Affairs for Chemistry Manufacturing & Controls CMC AbbVie Inc

Senior Regulatory Affairs Specialist Abbott Laboratories

Senior Staff Specialist, Regulatory Affairs Roth Staffing Companies

Senior Staff Specialist, Regulatory Affairs Apidel Technologies

Manager Regulatory Affairs-Chemistry Manufacturing & Controls CMC AbbVie Inc

Senior Director, Medical Affairs, BDPI – Vascular Platform Becton Dickinson Medical Devices

Associate Scientific Director Dermatology - US Medical Affairs AbbVie Inc

Associate Scientific DirectorScientific Director Dermatology - US Medical Affairs AbbVie Inc

Senior Director, Medical Affairs, BDPI - Vascular Platform Becton Dickinson and Co

Director, Medical Affairs (Nutrition) Fresenius Kabi AG

USGlobal Senior Medical DirectorScientific Director Medical Affairs - Multiple Myeloma AbbVie Inc

Head of State Government Affairs Vice President Allstate Insurance Company

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