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Associate Regulatory Compliance Specialist

Fresenius Kabi USA, LLC
life insurance, 401(k)
United States, Illinois, Lake Zurich
3 Corporate Drive (Show on map)
May 09, 2025
Job Summary The primary purpose of the Associate Regulatory Compliance Specialist position is to ensure that FK Regulatory Affairs remains up-to-date on all regulatory and licensing requirements and operates in compliance with federal, state, and internal organizational regulations and policies. This position will also continuously monitor organizational compliance, proactively identifies any impacts, and mitigates any operational risks. This position requires working on-site in Lake Zurich, IL 3 days per week. Remaining days may be worked remotely. Base salary range: $60,000-70,000. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities Maintain current knowledge of federal and international regulations/standards/guidance documents, and internal policies and procedures to ensure compliance within Regulatory Affairs. Support the implementation of emerging regulatory into business processes and system enhancements, and ensure the regulations are appropriately communicated and incorporated. Provide coaching/guidance to colleagues regarding regulatory requirements to enable ongoing compliance. Assist in the development, preparation and maintenance of Standard Operating Procedures (SOPs) and work instructions, and recommend changes to internal procedures in response to changes in regulations or standards. Prepare, verify, and/or maintain technical files pertaining to submissions or other FDA-required activities throughout the product lifecycle. Understand and support the regulatory implications of the product profile. Participate in strategic process improvement initiatives for key functions of Regulatory Affairs. Manage product data on both internal Regulatory Affairs and external FDA data tracking/collection databases to ensure the company's products, processes and physical sites continue to operate in a legal and ethical manner. May analyze data trends, product and process changes, support corrective action plans, produce reports from databases and present findings for leadership review and presentations. Assist in building a positive "culture of compliance" within the organization. Serve as backup to the Data Specialist in managing regulatory submission-related data. Other duties as assigned by management. Job Requirements Bachelor's degree required, preferably in a scientific discipline. 1+ years' experience in Regulatory Affairs (experience in Quality Assurance will be considered in lieu of Regulatory Affairs experience) Strong knowledge of applicable regulations, standards and guidelines. Excellent attention to the details. Ability to effectively manage large amounts of information for analysis and process/program improvements. Excellent written, verbal, and non-verbal communication skills. Solid organizational skills with capability to support multiple simultaneous projects. Strong technical (system) and computer skills with proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint, etc.). Strong problem solving and critical thinking skills. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.