Top 5 Regulatory affairs specialist Jobs in Illinois

Principal Regulatory Affairs Specialist
Cardinal Health —Waukegan, IL
- $80,900 - $127,050 a year
- Hybrid work
- Office
- Bachelor's degree
- No degree
- Paid parental leave
- Health savings account
Sr Regulatory Affairs Specialist- Medical Devices
Sunstar Americas, Inc. —Schaumburg, IL
- $93,381 - $144,000 a year
- Hybrid work
- Bachelor of Science
- Writing skills
- Office
- Profit sharing
- Paid holidays
Quick Apply
Regulatory Affairs Specialist
DEL MEDICAL INC —Bloomingdale, IL
- $50,000 - $60,000 a year
- Full-time
- Mid-level
- Master's degree
- Bachelor's degree
- AD&D insurance
- Dental insurance
Quick Apply
Regulatory Affairs Specialist III – Diabetes Care (on-site)
Abbott Laboratories —Buffalo Grove, IL
- $68,000 - $136,000 a year
- Full-time
- Bachelor's degree
- Experience equivalent to degree accepted
- In-person
- Health insurance
- Tuition reimbursement
Regulatory Affairs Specialist
Sterigenics —Oak Brook, IL
- $63,000 - $95,000 a year
- Full-time
- Management
- Mid-level
- Office
- Paid parental leave
- Paid holidays
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4d

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Sr Regulatory Affairs Specialist- Medical Devices
Sunstar Americas, Inc. —Schaumburg, IL
Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.
$93,381 - $144,000 a year
Quick Apply
Laboratory Specialist II - TEMP
Sysmex —Mundelein, IL
Upload data files or perform manual data entry as needed. Perform testing on prototype, investigational use and on-market clinical laboratory instruments,…
$34.32 - $53.94 an hour

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Principal Regulatory Affairs Specialist

Cardinal Health -
Waukegan, IL

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Job Details

$80,900 - $127,050 a year

Benefits

Paid parental leave
Health savings account
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Parental leave
Vision insurance

Qualifications

FDA submissions
Document review (document control)
Content creation for technical audiences
Standard Operating Procedures (SOPs) implementation
Technical documentation
Risk mitigation strategy implementation
Regulatory legal research
Policy & process development
Product development projects
Bachelor's degree
Mentoring
Interdisciplinary policy and procedure development experience
Project execution
Regulatory submission editing and review
Design controls
Biomedical regulatory compliance
Healthcare regulatory compliance policy development
Senior level
Technical writing experience within technology
Standard operating procedures (SOPs)
Communication skills
Policy Development

Full Job Description

What Regulatory Affairs contributes to Cardinal Health

Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

Location: The ideal candidate will reside within a reasonable commuting distance of one of our office locations: Waukegan, IL or El Paso, TX

Schedule: Hybrid. 1-2x a week in office.

Job Summary

The Principal Regulatory Affairs Specialist will support the Medical Solutions Regulatory affairs team. They are responsible for regulatory activities associated with convenience kitting (Presource® kitting). This includes being regulatory lead for strategy, 510ks, and FDA regulations for the kitting products.

Responsibilities

Lead new and modified product development projects to establish and integrate regulatory strategy into project activities.
Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.
Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution.
Review design control documents including documents associated with design inputs and design outputs.
Review product labeling for compliance with global labeling regulations.
Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business.
Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.
Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc.
Development and implementation of regulatory procedures and SOPs.

Qualifications:

Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred.
5-7 years regulatory affairs experience preferred.
Experience in medical device industry a plus.
Proficiency in US FDA medical devices regulations highly preferred.
Strong organizational and problem-solving skills.
Strong oral and written communication skills.
Ability to manage multiple projects while maintaining deadlines.
Ability to travel up to 10% of the time.

What is expected of you and others at this level

Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems
Solutions are innovative and consistent with organization objectives
Completes work; independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues

Anticipated salary range: $80,900 - $127,050

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs

Application window anticipated to close: 06/21/2026 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. 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.

#LI-Hybrid

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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regulatory affairs specialist jobs in illinois

Principal Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist- Medical Devices

Regulatory Affairs Specialist

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

Regulatory Affairs Specialist

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