Senior Manager, US Licensure, UDI

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver DS Quality oversight for UDI processes, shared procedures, and the lifecycle management of UDI data (collection, storage, distribution).

• Lead and enhance end-to-end global UDI processes to ensure compliance and operational excellence across various functions and markets.

• Act as the DS Quality representative in the UDI Governance forum and facilitate strategic collaborations among Supply Chain, Quality, R&D, and Regulatory Affairs.

• Supervise audit readiness and compliance with emerging UDI regulations to safeguard country-level right-to-sell across DS businesses.

• Design, establish, maintain, and enhance the DePuy Synthes governance model for USA manufacturing, selling, and distribution licensing in collaboration with cross-functional stakeholders.

• Serve as the US Licensure Subject Matter Expert (SME) for DS: collect and manage data for licensure applications/renewals, coordinate filings with approved third-party teams, and maintain documentation.

• Develop and uphold Standard Operating Procedures (SOPs), work instructions, training materials, and remediation oversight as necessary.

• Lead or assist in project management activities and the creation of a digital tool/solution to support end-to-end licensure and UDI processes.

• Carry out activities under GxP and ensure continuous 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 setting.

• Strong skills in planning, project management, and change management.

• Comprehensive knowledge of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485).

• Experience in Process Excellence (Lean, Six Sigma) across diverse business areas or equivalent quality standards programs.

• Ability to successfully execute work in a highly matrixed, cross-functional, and often ambiguous environment.

• Bachelor's degree required (Engineering, Life Sciences, Regulatory Affairs, or a related field).

• An advanced degree (Master’s, MBA, or equivalent) is 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 residing in the State of Colorado – 48 hours per calendar year; for employees residing 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.