Senior Manager, US Licensure, UDI

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🔥 8 minutes ago

🇺🇸 United States – Remote

💵 $122k - $212.8k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• 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

• 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

• 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