Medline Industries, LP · 4 days ago
Principal Toxicologist
Northfield, IL
Full-time
Onsite
Lead/Staff
$153K/yr - $229K/yr
10+ years expMedline Industries, LP is a growing worldwide organization focused on product safety and compliance in medical devices and related fields. The Principal Toxicologist will provide strategic guidance and scientific expertise to cross-functional teams, ensuring product safety through toxicological risk assessments and mentoring junior staff.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Provide strategic input for regulatory submissions (e.g., 510(k), CE marking, PMDA) and interact with global regulatory bodies
Conduct and lead toxicological risk assessments for new and existing medical devices, components, and materials
Develop and implement strategies for biological evaluation to ensure compliance with global regulatory standards, such as those from the FDA and EU MDR
Stay current with emerging trends and advancements in the field of toxicology and product safety and integrate predictive toxicology tools into safety assessments
Mentor and guide junior toxicologists and scientists, fostering technical growth and knowledge sharing
Conduct and interpret chemical characterization (e.g., E&L studies, ISO 10993-18, ISO 18562), SAR/QSAR modeling, and guide biocompatibility testing under GLP requirements
Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs
Advise on potential risks and hazards associated with product materials and processes
Independent problem solver who can use a methodical approach to develop solutions and make recommendations
Represent the organization in external forums, regulatory meetings, and industry working groups (e.g., ASTM, ISO)
Qualification
Required
Bachelor's degree in Toxicology, Pharmacology, or a related scientific field
10+ years of experience in toxicology, with a significant focus on medical devices or a closely related industry (e.g., pharmaceutical, biotech) and toxicological risk assessments, biocompatibility assessments, and chemical characterization
In-depth knowledge of toxicology principles, risk assessment methodologies, and global regulations like ISO 10993, ISO 18562, ISO 14971, FDA, and EU MDR
Must possess excellent communication (written and verbal), leadership, and problem-solving skills
The ability to manage multiple projects simultaneously and work effectively in a matrixed environment is critical
Preferred
A Diplomate of the American Board of Toxicology (DABT) or equivalent certification is highly desirable
Experience of quality audit by external regulatory bodies (FDA, EU Regulatory body, etc.)
Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists
Experience communicating with internal and external business partners and cross functional teams with various audiences
Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site
Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem-solving skills
Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates
Ability to influence and motivate others to drive results in a multi-location and matrixed environment
Ability to manage multiple projects in cross functional teams
Comfortable in a dynamic environment and able to work independently as well as on teams
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline Industries, LP
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline Industries, LP 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
2026-01-07
2025-12-26
TheStreet.com
2025-12-20
Company data provided by crunchbase