Job Description

The Compliance Project Manager is a hands-on role responsible for executing and driving completion of critical quality and regulatory initiatives. This role is accountable for day-to-day program execution, ensuring tasks are clearly defined, owned, communicated, tracked, and completed on time with appropriate documentation to support regulatory compliance.

Responsibilities:

• Manage all aspects of internal projects regarding ongoing compliance of medical devices, dietary supplements, cosmetics, and/or OTC/ANDA/NDA drugs.
• Leading collaborative, multifunctional teams consisting of stakeholders of various levels across R&D, quality, regulatory, manufacturing, and product divisions.
• Driving cross-functional quality and regulatory compliance initiatives, including FDA 483 response programs, CAPA remediation efforts, and internal process improvement projects.
• Serve as a central coordinator to ensure timely, compliant, and traceable execution of commitments with strong alignment to regulatory requirements and business objectives.
• Maintain team engagement by ensuring timely and transparent communication.
• Lead process improvement initiatives.

Qualifications:

• Education: Bachelor's degree in Engineering or Science related field.
• Work Experience: At least 2 years of experience in a medical device or pharmaceutical related field.
• Knowledge / Skills / Abilities:
  • Project Management
  • Microsoft Project or Smartsheet
  • Knowledge of medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
  • Position may require travel up to 10% of the time for business purposes (domestic and international).

Preferred Qualifications:

• PMP Certification
• Experience with regulatory agency communications
• Experience with audits/inspections
• Strong working knowledge of QMS elements, CAPA processes, and FDA/ISO requirements.
• Highly organized with strong attention to detail and follow-through.
• Ability to drive execution and hold action owners accountable in a fast-paced environment.
• Strong communication skills with ability to work across all levels of the organization.
• Proficiency with tracking and reporting tools (e.g., Smartsheet, Excel dashboards)
• Working familiarity with data structures and concepts (e.g., data lakes, data pipelines, or enterprise data environments)
• Exposure to supporting implementation or updates of software systems

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:

$92,000.00 - $138,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here

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.