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Spec Regulatory UDI Operations

Medline Industries, LP · Northfield, IL, United States

Corporate LawEntry LevelExternal listingfull-time8 days ago

About The Role

  • Bachelor’s Degree in technical field or High School Diploma with extensive job experience.

Work Experience

  • At least 2 years of experience in Quality or Regulatory Affairs for a regulated industry.

Knowledge / Skills / Abilities

  • Proficient in MS Office Suite products (Word, Excel, PowerPoint, Outlook).
  • Proven experience leading projects and driving process improvements through critical thinking and problem solving.
  • Ability to review, evaluate, and reconcile complex data and documentation with high attention to detail.
  • Experience interpreting and evaluating compliance with standards, laws, and regulations.

PREFERRED JOB REQUIREMENTS

  • Bachelor’s degree in regulatory affairs or life sciences field.

Work Experience

  • At least 3 years of experience in Quality or Regulatory Affairs for a regulated industry.

Knowledge / Skills / Abilities

  • Working knowledge of FDA product codes, product class structure, Quality Management Systems, and Good Manufacturing Practices.
  • Strong communication and relationship-building skills; demonstrated project management, critical thinking, and problem-solving abilities to deliver results and meet deadlines.
  • Ability to assess regulatory risk and recommend mitigation strategies.

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

$73,000.00 - $110,000.00 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.

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