Senior Manager, US Licensure, UDI
Location
United States
Posted
1 day ago
Salary
$122K - $212.8K / year
Seniority
Senior
Job Description
Senior Manager, US Licensure, UDI
Johnson & Johnson
• 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.
Job 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.
- Bachelor's degree required (Engineering, Life Sciences, Regulatory Affairs, or related field).
- Advanced degree (Master’s, MBA, or equivalent) preferred.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
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