Medline · 10 hours ago
Regulatory Affairs Specialist
Northfield, IL
Full-time
Onsite
Entry, Mid Level
$79K/yr - $119K/yr
2+ years expMedline is a growing worldwide organization that specializes in healthcare products and solutions. They are seeking a Regulatory Affairs Specialist to plan and execute global regulatory activities necessary for obtaining and maintaining regulatory approvals for medical devices.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s)
Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways and strategies
Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met
Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical information, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators
Participate in the development, review, and substantiation of product labeling and claims
Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert
Qualification
Required
B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
2 years of experience in medical device regulatory affairs or quality assurance
Understanding of the current Regulatory environment and demonstrating the ability to perform within
Applied knowledge of FDA regulations and guidelines
Ability to evaluate information to determine compliance with standards, laws, and regulations
Travel required up to 5%
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
Packaging-Gateway.com
2026-01-16
2026-01-13
Company data provided by crunchbase