Senior Manager, US Licensure, UDI

Location

United States

Posted

1 day ago

Salary

$122K - $212.8K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglish

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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