Full-Time
Regulatory Affairs Specialist
Posted on 11/1/2025
Medline
10,001+ employees
Manufacturer and distributor of medical supplies
Compensation Overview
$79.6k - $115.4k/yr
New Mexico, USA + 55 more
More locations: Washington, USA | Kansas, USA | Pennsylvania, USA | North Dakota, USA | Oregon, USA | Delaware, USA | Iowa, USA | California, USA | Washington, DC, USA | Vermont, USA | Wyoming, USA | Texas, USA | Montana, USA | Jackson Township, NJ, USA | Florida, USA | Northbrook, IL, USA | Waterbury, CT, USA | Nevada, USA | South Carolina, USA | South Dakota, USA | Georgia, USA | Arizona, USA | Concord, NH, USA | Morgantown, WV, USA | Berkeley Springs, WV, USA | Mississippi, USA | Virginia, USA | Arkansas, USA | Minnesota, USA | Colorado, USA | West Redlands, Redlands, CA, USA | Nebraska, USA | Rhode Island, USA | Utah, USA | Kentucky, USA | New York, NY, USA | Maryland, USA | Hawaii, USA | Wisconsin, USA | Maine, USA | Massachusetts, USA | North Carolina, USA | Oklahoma, USA | Huntington, WV, USA | Missouri, USA | Beckley, WV, USA | Ohio, USA | Indiana, USA | Louisiana, USA | Alaska, USA | Michigan, USA | Illinois, USA | Alabama, USA | Charleston, WV, USA | Idaho, USA
Remote
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 Legal & Compliance (1) |
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- Education: B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
- Work Experience: 2 years of experience in medical device regulatory affairs or quality assurance.
- Knowledge / Skills / Abilities: Understanding of the current Regulatory environment and demonstrating the ability to perform within.
- Knowledge / Skills / Abilities: Applied knowledge of FDA regulations and guidelines.
- Knowledge / Skills / Abilities: Ability to evaluate information to determine compliance with standards, laws, and regulations.
- Travel: Travel required up to 5%.
- In support of business priorities, 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.
Medline Industries designs, produces, and distributes medical supplies for healthcare settings. It combines manufacturing and distribution to control product quality and sell directly to hospitals and other healthcare providers, offering a wide range of Medline-branded and third-party products. Its products include gowns, uniforms, gloves, and other medical consumables, produced and then delivered through a direct-to-provider model. The company differentiates itself with vertical integration that bypasses traditional distributors, a long-standing family-led culture that continued after a 2021 private-equity-led majority investment, and the scale to serve healthcare systems with a broad catalog. The goal is to supply healthcare providers with a comprehensive, high-quality catalog of medical products while expanding market reach and maintaining reliability through direct manufacturing-and-distribution control.
Company Size
10,001+
Company Stage
IPO
Headquarters
Northfield, Illinois
Founded
1966
Simplify's Take
What believers are saying
- Automation expansion improves throughput; Aurora’s AutoStore adds 96 robots and 38,000 bins.
- Slovakia capacity expansion strengthens European supply resilience, with production targeted for 2027.
- Cross-selling laboratory products expands Medline beyond med-surg into adjacent hospital procurement budgets.
What critics are saying
- FDA warning letters in April and June 2026 expose recurring manufacturing quality failures.
- Tariff costs and higher operating expenses are compressing margins faster than sales growth.
- Heavy leverage after the 2025 IPO and 2026 refinancing limits flexibility if disruptions worsen.
What makes Medline unique
- Medline combines manufacturing and distribution, controlling quality and direct hospital access.
- Its 1966 family roots and 2021 Blackstone-led buyout preserve continuity and scale.
- The company serves over 100 countries with 335,000 healthcare products, including 190,000 Medline-branded.
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Growth & Insights and Company News
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↓ -1%Medline draws another US FDA warning in two months over quality lapses. By Thomson Reuters Jun 3, 2026 | 9:39 AM June 3 (Reuters) - The U.S. FDA issued a warning letter to medical device maker Medline over violations of manufacturing quality standards, the second such action against the company in two months. The Food and Drug Administration, in its letter dated May 28, said the company failed to thoroughly investigate microbial contamination incidents in finished drug products and also cited inadequate cleaning practices. This follows an FDA warning letter in April that flagged defects in Medline's syringes used in heart procedures and warned of enforcement action if the issues were not addressed. In its latest letter, the FDA said Medline's probe into the contaminated samples was inadequate and faulted the company for not explaining why earlier corrective actions had failed, warning that such lapses may pose a patient safety hazard. "Following an inspection of our ReadyCare Waukegan facility (in Illinois), we implemented significant improvements in our production processes and plant operations to ensure the highest levels of quality," the company said in an emailed response. The FDA has directed Medline to provide an independent risk assessment of all contamination hazards in its manufacturing processes, equipment and facilities, along with a remediation plan and timelines. The regulator said Medline's manufacturing operators have routinely deviated from cleaning and disinfection procedures, and also flagged manufacturing lapses at other facilities in the company's network. It added that "repeated failures at multiple sites" demonstrate inadequate management oversight and control, and said the company should assess its operations to ensure they conform to FDA requirements. The company said it is continuing to fully engage with the FDA related to both its Waukegan facility and its other drug manufacturing sites. Failure to address this matter may result in regulatory or legal action, the FDA said. The company must respond within 15 days of receiving the letter. (Reporting by Sneha S K in Bengaluru; Editing by Vijay Kishore)
Woman's Hospital selects Medline as its laboratory Prime Vendor. May 18, 2026 - Medline announced that it signed an expanded Prime Vendor agreement with Baton Rouge-based Woman's Hospital, which specializes in high-quality care for women and infants and is the largest delivery service in Louisiana and among the largest in the nation. The hospital provides maternity care, infant care, maternal mental health care and cancer treatment to patients across the state. With this new agreement, Woman's Hospital will have access to Medline's comprehensive portfolio of laboratory products, in addition to medical-surgical products. The agreement also provides access to Medline's distribution capabilities to help support more efficient ordering, improved inventory visibility and reliable delivery.
Medline neurosurgical sponge recall: A Staritas resource to support informed substitution decisions. On March 13, 2026, Medline announced a voluntary recall of its neurosurgical sponges due to elevated endotoxin levels. All affected products must be destroyed, and there is currently no timeline for return, creating an immediate supply disruption for providers that rely on these sponges for critical procedures. Neurosurgical sponges are essential in delicate operations where sterility, precision, and absorbency are non-negotiable. This recall presents more than a sourcing challenge. Clinical teams must rapidly evaluate alternatives, supply chain leaders must secure inventory in a constrained market, and finance teams must manage pricing volatility, all while ensuring continuity of care. To support providers navigating this disruption, Staritas has developed a Functional Equivalence Report identifying U.S. alternatives to the recalled Medline products. The report goes beyond a substitute list by offering structured comparisons across key clinical specifications such as size, materials, absorbency, and intended use. This approach helps teams assess safety and performance with confidence. The report also includes Supply Guide price benchmarks, giving supply chain and finance leaders critical visibility into market pricing at a time when demand shifts and cost pressures are high. Together, these insights empower faster, more informed decision-making, strengthen cross-functional alignment, and help make every choice clear. While recalls are disruptive, they also underscore the importance of preparedness, including clear cross-department communication, supplier diversification, and data-driven inventory management. With the right tools and insight, organizations can respond strategically rather than reactively. Staritas partners with healthcare organizations to navigate disruptions like this one by turning uncertainty into informed action and helping ensure patient care continues without compromise. Explore how Staritas Functional Equivalents and Recall Management solutions can help you quickly identify appropriate alternatives, assess risk exposure, and respond to disruptions with clarity and confidence.
Medline receives FDA warning letter on its heart procedure syringes. April 09, 2026 01:29 PM CDT The Food and Drug Administration has sent a warning letter to Medline Industries over reported issues with syringes used in cardiac procedures and the company could face regulatory action if the issues are not corrected. Staying current is easy with newsletters delivered straight to your inbox.
FDA flags quality system lapses at Medline facility over device risks. Stock score locked: want to see it? Benzinga Rankings give you vital metrics on any stock - anytime. The U.S. Food and Drug Administration has issued a warning letter to Medline Inc. (NASDAQ:MDLN), following an inspection that identified significant quality system violations tied to its cardiovascular device kits, raising concerns about patient safety and regulatory compliance. FDA flags manufacturing and quality system failures. The inspection, conducted between December 1 and December 12, 2025, at Medline's New York facility, found that the company's angiographic control syringes and related components failed to meet current good manufacturing practice standards. The FDA determined the devices were "adulterated" under federal law due to deficiencies in manufacturing controls, quality systems, and compliance with established regulations. CAPA process breakdown raises safety concerns. The letter dated March 25 highlighted Medline's failure to properly implement corrective and preventive action (CAPA) procedures. Despite 221 complaints and 177 medical device reports tied to syringe disconnections, the company's corrective actions - such as scrapping inventory and increasing cleaning frequency - were deemed insufficient relative to the risk. The FDA noted inconsistencies in Medline's risk assessments, particularly where internal analyses flagged severe risks like air embolism, while the company classified the overall risk as low. Complaint trends also remained above established thresholds even after corrective actions were introduced, yet the company did not escalate or reopen investigations as required. Device recall and ongoing investigations. Medline acknowledged the shortcomings, closed the initial CAPA, and initiated new investigations alongside a product removal plan. The company submitted a formal report to the FDA in March 2026 outlining the removal of affected devices. However, regulators flagged gaps in the scope and timeline of these actions, including unclear investigation deadlines and inconsistencies in manufacturing data tied to complaint rates. Medline contamination risks and cleaning deficiencies. The FDA also cited failures in maintaining cleanroom standards, with visible particulate matter found on manufacturing equipment. More than 100 complaints related to foreign material contamination were recorded over two years. While Medline implemented corrective cleaning measures and updated procedures, the FDA said the company did not adequately assess the impact on products already in the market. Further violations involved inadequate design verification processes. The FDA found insufficient documentation supporting testing decisions for device components, raising questions about whether all affected products met required standards. Regulatory risks and next steps. The FDA warned that failure to address these issues could lead to enforcement actions, including fines or product seizures. Medline has been directed to submit a detailed remediation plan within 15 business days and align all corrective actions with updated Quality Management System Regulation requirements that took effect in February 2026. In February, Medline identified electrical safety risks with its Medline Basic Homecare Beds that may lead to fire. MDLN Price Action: Medline shares were up 2.93% at $45.64 at the time of publication on Thursday, according to Benzinga Pro data. Everyone Bought NVIDIA. The Smart Money Is Now Buying What NVIDIA Needs to Run. The chip trade is crowded. Valuations are stretched. The investors who made money on Phase 1 of AI are already repositioning into the one thing every data center depends on: uninterrupted power. Natural gas and nuclear are the only sources that can deliver it at scale - and one small company just landed a deal to power multiple new hyperscale data centers. Posted In: