Senior Manager, US Licensure and UDI

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Sr. Manager, US Licensure and UDI role will provide global commercial quality oversight and end-to-end (E2E) process improvement for UDI management and USA selling and Board of Health required licensure. Ensure regulatory compliance, audit readiness, and operational excellence by partnering cross-functionally (Supply Chain, Quality, R&D, RA) and by establishing sustainable governance, procedures, and digital solutions. Ideal for an experienced quality expert who can translate regulatory requirements into scalable, compliant E2E processes and lead cross-functional delivery of UDI and USA manufacturing and distributing licensing programs.

Key Responsibilities

• 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.

Qualifications

Education

• Bachelor’s degree required (Engineering, Life Sciences, Regulatory Affairs, or related field).
• Advanced degree (Master’s, MBA, or equivalent) preferred.

Experience and Skills

• 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

Other:

• Travel: Limited; Up to 20%, domestic and international.
• Certifications: ASQ, PMP, or similar certifications preferred but not required.
• Language: English required; additional languages a plus.