Full Job Description
Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Remote (US)
Job Description:
We are searching for the best talent for Senior Manager, US Licensure and UDI to join our DePuy Synthes Quality organization located in the United States.
This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
About Orthopaedics
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
The Sr. Manager, US Licensure and UDI role will provide global commercial quality oversight and end-to-end (E2E) process improvement for UDI management and USA selling and Board of Health required licensure. Ensure regulatory compliance, audit readiness, and operational excellence by partnering cross-functionally (Supply Chain, Quality, R&D, RA) and by establishing sustainable governance, procedures, and digital solutions. Ideal for an experienced quality expert who can translate regulatory requirements into scalable, compliant E2E processes and lead cross-functional delivery of UDI and USA manufacturing and distributing licensing programs.
Key Responsibilities
• 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.
Qualifications
Education
• Bachelor's degree required (Engineering, Life Sciences, Regulatory Affairs, or
related field).
• Advanced degree (Master's, MBA, or equivalent) preferred.
Experience and Skills
Required:
• 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
Preferred:
• 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
Other:
• Travel: Limited; Up to 20%, domestic and international.
• Certifications: ASQ, PMP, or similar certifications preferred but not required.
• Language: English required; additional languages a plus.
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
#LI-Remote
Required Skills:
Preferred Skills:
Business Alignment, Compliance Management, Consulting, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Organizing, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Stakeholder Engagement, Standard Operating Procedure (SOP), Technical Credibility
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00
Additional Description for Pay Transparency:
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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
