Medline Industries, LP · 3 days ago
Sr. Regulatory Affairs Specialist
Illinois, United States
Full-time
Hybrid
Mid, Senior Level
$87K/yr - $131K/yr
4+ years expMedline Industries, LP is a growing worldwide organization seeking a Senior Regulatory Affairs Specialist responsible for planning and executing complex global regulatory projects. The role involves developing regulatory strategies for new devices and managing submissions and regulatory filings to ensure compliance with regulations.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s). Identify factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance
Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, and solutions for specific products and scenarios
Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards
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
Participate in the development, review, and substantiation of product labeling and claims
Manage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions
Assist in the review and development of processes related to regulatory activities of responsibility
Assist in the establishment and maintenance of department databases, logs, and files necessary for ensuring ongoing compliance
Actively participate in internal and external audits when applicable
Qualification
Required
B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets
Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files
Experience preparing responses and communicating with regulatory agencies
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
Position requires up to 10% travel
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
2025-12-26
TheStreet.com
2025-12-20
2025-12-19
Company data provided by crunchbase