Senior Manager, US Licensure, UDI

Johnson & Johnson

Senior Manager overseeing quality compliance for UDI processes and regulatory requirements at Johnson & Johnson. Drive operational excellence within a remote team in the medical device sector.

Posted 7/17/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $122,000 - $212,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality and Regulatory Affairs within the medical device sector, with a strong focus on UDI processes, compliance, and audit readiness. Proven ability to lead cross-functional initiatives and drive process improvements in a global, matrixed environment.

Highest-signal resume keywords

UDI Process OversightGlobal Medical Device RegulationsProject Management ExpertiseProcess Excellence (Lean, Six Sigma)US Licensure Regulations Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality OversightRegulatory ComplianceAudit ReadinessSOP DevelopmentData ManagementProcess ImprovementDigital Quality SystemsChange ManagementLicensure Application ManagementE2E Process Management

Soft Skills

Excellent Communication SkillsCross-Functional CollaborationStrategic FacilitationAdaptability in Ambiguous Environments

Certifications & Qualifications

Qualified Notary Public

Industry Keywords

Medical DeviceRegulated HealthcareFDAEU MDRISO 13485GxPHealth Authority AuditsCompliance Monitoring

About the role

Key responsibilities & impact

Provide DS Quality oversight for UDI processes, shared procedures, and lifecycle management of UDI data (collection, storage, distribution).
Lead and continuously improve E2E global UDI processes to drive compliance and operational excellence across functions and markets.
Serve as DS Quality representative in the UDI Governance forum and facilitate strategic interfaces among Supply Chain, Quality, R&D and Regulatory Affairs.
Oversee audit readiness and compliance with emerging UDI regulations to protect country-level right-to-sell across DS businesses.
Design, establish, maintain, and improve the DePuy Synthes governance model for USA manufacturing, selling, and distribution licensing in partnership with cross-functional stakeholders.
Act as the US Licensure SME for DS: gather and manage data for licensure applications/renewals, coordinate filings with approved 3rd-party teams, and maintain documentation.
Develop and maintain SOPs, work instructions, training materials, and remediation oversight as needed.
Lead or support project management activities and the development of a digital tool/solution to support E2E licensure and UDI processes.
Execute activities under GxP and ensure ongoing audit readiness.

Requirements

What you’ll need

A minimum of 8-10 years of experience in Quality, Regulatory Affairs, or Compliance within a medical device and/or regulated healthcare environment.
Strong planning, project management, and change management expertise.
Strong working knowledge of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485).
Process Excellence (Lean, six sigma) experience across diversified business areas or equivalent quality standards programs.
Successfully executes work in a highly matrixed, cross functional, often ambiguous environment.
Knowledge of legal elements of US Licensure Regulations.
Extensive experience in US Health Authority audits.
Experience operating in a global, matrixed MedTech organization.
Track record of driving large-scale process improvement and transformation initiatives.
Familiarity with digital quality systems and data-driven compliance monitoring.
Excellent written and verbal communication skills, including interaction with regulatory authorities.
Qualified Notary Public is a plus.

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year