Job Summary

Responsible for planning and executing regulatory activities necessary to obtain and maintain state and federal licensure for the distribution of drugs, medical devices, and other regulated products.
Prepare comprehensive regulatory strategies for distribution center licensing, customer licensing, and/or vendor licensing, ensuring that operational and business units comply with all regulatory requirements for regulatory licensing.
May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals.

Job Description

Responsibilities

• In support of business priorities, determine the requirements for obtaining and complying with state and federal licenses for the distribution of regulated products.

• Prepare, complete, and submit licensing applications, documents, to state and federal regulatory agencies.

• Research federal, state, or local licensing requirements through review of laws and regulations or by direct contact with regulatory authorities.

• Communicate requirements of regulations to internal or external customers.

• Review and provide feedback on documentation and procedures to ensure applicable regulatory requirements are met.

• Maintain department databases, logs, and files.

• Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert.

• Train new team members on Medline licensing procedures and processes.

Required Experience

• Bachelor’s degree or combination of education and experience

• At least 2 years of experience in regulatory affairs, licensing, quality assurance, compliance, or legal.

Knowledge / Skills / Abilities

• Intermediate skill level in Microsoft Suites (Excel, Word, Visio, Access, PowerPoint, Project).

• Ability to evaluate information to determine compliance with standards, laws, and regulations.

• Applied knowledge of state pharmacy/ wholesale drug distributor laws, NABP Drug Distributor Accreditation, FDA regulations, DSCSA, and other laws and regulations related to drug and medical device distribution.

• Experience collaborating with internal resources and external resources.

• Experience working through details of a problem, overcoming obstacles, and reaching a positive and successful solution

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$63,960.00 - $92,560.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.