Senior Manager, US Licensure, UDI

Posted 52mins ago

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Senior Manager for US Licensure and UDI in DePuy Synthes. Overseeing quality, compliance, and governance in medical device processes across the USA.

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.

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.

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