Senior Manager, Regulatory Compliance – Medical Events, Vigilance & AE Case Reporting

Medline Industries, LP

. Lead and manage medical events, Medical Device Vigilance, and drug, biologic, combination-product, and consumer-product adverse-event activities .

Posted 10/23/2026full-timeNorthfield • Illinois • United StatesSenior💰 $154,000 - $231,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing medical device vigilance and pharmacovigilance activities, including regulatory reporting and adverse-event management. Proven ability to lead teams, oversee compliance with global regulations, and implement process improvements in a cross-functional environment.

Highest-signal resume keywords

Medical Device Vigilance ManagementPharmacovigilance ActivitiesRegulatory Reporting ExperienceAdverse Event ManagementTeam Leadership and Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Complaint ManagementRegulatory ReportingICSR ProcessingADR ReportingMedDRA Safety CodingEvent CodingCase ManagementMedical Event AssessmentPostmarketing Safety ReportingQuality Management Systems

Soft Skills

CollaborationCoachingProcess ImprovementMotivating TeamsCommunication

Tools & Technologies

Microsoft WordMicrosoft Excel

Certifications & Qualifications

RNPharmD/RPhMedDRA Coding Training/Certification

Industry Keywords

Adverse EventPharmaceuticalMedical DeviceQuality ManagementRegulatory InspectionsGlobal RegulationsPatient SafetyPost-Market SafetyClinical EvaluationRisk Management

About the role

Key responsibilities & impact

Lead and manage medical events, Medical Device Vigilance, and drug, biologic, combination-product, and consumer-product adverse-event activities
Manage the Medical Device Vigilance program and personnel responsible for clinical evaluation, complaint management, reportability assessment, regulatory reporting, follow-up, and event coding
Oversee evaluation and reporting of potentially reportable medical device events under global requirements
Manage adverse-event and pharmacovigilance activities, including case management, assessment, follow-up, documentation, coding, reconciliation, and regulatory reporting
Oversee ICSR, ADR, periodic safety, and postmarketing safety reporting activities
Manage MedDRA/IMDRF safety coding and ensure medically relevant, consistent coding
Oversee adverse-event reconciliation across applicable functions
Oversee complaint risk assessments and escalation through Quality and Post-Market Risk Management processes
Monitor information for potential safety signals and escalate for additional assessment
Collaborate with international and cross-functional partners on global safety activities and continuous improvement
Maintain knowledge of global regulations, guidance, and standards
Support FDA, Notified Body, MDSAP, and other regulatory inspections and audits
Provide global training and coaching on adverse-event identification, reporting, device vigilance, pharmacovigilance, and compliance
Identify process, procedure, system, and training improvements
Manage through multiple Managers and/or Supervisors
Oversee major projects, programs, outcomes, and budget responsibility
Interpret, execute, develop, recommend, and implement departmental and project policies
Hire staff, recommend pay increases, conduct performance reviews, train and develop staff, estimate personnel needs, assign work, and ensure completion dates and consistent policy application

Requirements

What you’ll need

Bachelor's degree with a scientific, clinical, nursing, pharmacy, life sciences, or related technical background
At least 5 years of experience in medical device and pharmaceutical Quality Management Systems, including complaint management, regulatory reporting, pharmacovigilance, drug safety, adverse event management, or related Quality/Patient Safety activities within medical device and/or pharmaceutical environments
At least 2 years of experience managing people, including hiring, developing, motivating, and directing people
Experience with FDA medical device and/or pharmaceutical postmarket reporting requirements
Experience supporting regulatory inspections and audits involving post-market safety, medical device vigilance, or pharmacovigilance
Experience working within global and cross-functional quality/regulatory environments
Strong knowledge of medical-event assessment, device vigilance reporting, adverse event management, and pharmacovigilance principles
Knowledge of ICSR processing, ADR reporting, and postmarketing safety reporting principles
Knowledge of medical terminology and MedDRA and IMDRF safety coding systems
Ability to evaluate complex medical and adverse-event information and direct case assessment, follow-up, escalation, and regulatory reporting
Ability to interpret and apply regulatory requirements across multiple products and jurisdictions
Ability to lead teams responsible for time-sensitive and regulated safety activities
Position may require domestic and/or international business travel
RN, PharmD/RPh, or other relevant healthcare professional credential preferred
MedDRA coding training/certification or equivalent safety-coding experience preferred
Advanced Microsoft Word and Excel experience preferred

Benefits

Comp & perks

Competitive total rewards package
Continuing education & training
Health insurance
Life and disability insurance
401(k) contributions
Paid time off
Employee Assistance Program (for roles under 30 hours per week)
Employee Resource Groups (for roles under 30 hours per week)
Employee Service Corp (for roles under 30 hours per week)
Bonus and/or incentive eligibility
Career growth opportunities
Diversity, inclusion, and belonging resources