Senior Manager, Regulatory Affairs – MedTech

Fresenius Kabi USA

Senior Regulatory Affairs Manager guiding high-risk medical product strategies and submissions at Fresenius Kabi, a global healthcare company. Leading compliance, health-authority interactions, and lifecycle oversight for injectable medicines and medical technologies.

Posted 8/17/2026full-timeLake Zurich • Illinois • 🇺🇸 United StatesSenior💰 $160,000 - $170,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory decision-making and strategy, with a strong focus on compliance and effective collaboration with regulatory agencies. Capable of leading complex regulatory submissions and providing strategic input for product development and business decisions.

Highest-signal resume keywords

Regulatory Strategy DevelopmentRegulatory Submissions OversightRegulatory Compliance MonitoringInterpersonal SkillsExperience with Infusion Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Decision-MakingRegulatory SubmissionsRegulatory ComplianceProblem-Solving SkillsUnderstanding of Regulatory RequirementsComplex Regulatory StrategiesPost-Market Regulatory ComplianceHealth Authority InteractionsProduct Labeling ReviewTechnical Oversight

Soft Skills

Advanced Interpersonal SkillsConflict ManagementStakeholder InfluenceEffective Collaboration

Industry Keywords

Device Regulatory RequirementsDrug Regulatory RequirementsInfusion SystemsTransfusion TechnologiesCellular TherapiesGovernment TendersPADERsPSURsPMS/PMCF ReportsRegulatory Agency Relationships

About the role

Key responsibilities & impact

Own regulatory decision-making and strategy for assigned product lines, projects, regions, or regulatory initiatives involving significant complexity or regulatory risk
Prepare, author, coordinate, or provide senior technical oversight for U.S. and/or international regulatory submissions, including responses to regulatory agency questions
Approve regulatory strategies developed by Managers and below
Represent Regulatory as the senior Regulatory Affairs lead on assigned product/project teams and align worldwide regulatory strategies with business objectives
Maintain communications within Regulatory and across functions to align technical positions, escalation decisions, and consistent execution
Provide strategic and technical input for product development, project plans, and business decisions
Monitor evolving regulatory requirements, assess impacts on assigned products/projects or technologies, and ensure compliance
Review and approve product labeling and advertising/promotional materials for regulatory compliance
Support regulatory activities for government tenders/initiatives, including professional certifications if required
Ensure post-market regulatory compliance, including annual reports, PADERs, PSURs, and PMS/PMCF reports where applicable
Lead complex Health Authority interactions, including meetings, negotiations, and responses
Develop and maintain effective relationships with regulatory agencies
Mentor and train other regulatory team members

Requirements

What you’ll need

Bachelor’s Degree
8+ years of experience in a regulatory function
Strong technical, regulatory, and problem-solving skills
Understanding of device and/or drug regulatory requirements, their foundation, and submission processes
Demonstrated experience providing and executing complex regulatory strategies and/or managing novel regulatory challenges
Advanced interpersonal skills and ability to manage conflict situations and influence stakeholders
Proven effective collaboration with regulatory agencies
Experience with infusion systems, transfusion technologies, cellular therapies, or drugs preferred
Ability to effectively speak, read, write, and understand English
Must be able to independently understand policies, procedures, training materials, and workplace communications written in English
Position is not eligible for visa sponsorship now or in the future

Benefits

Comp & perks

Annual bonus plan with a target of 14% of base salary
401(k) plan with company contributions
Paid vacation, holiday and personal days
Employee assistance program
Medical coverage
Prescription drug coverage
Dental coverage
Vision coverage
Life insurance
Disability coverage
Wellness program