Senior Manager, US Licensure and UDI

Johnson & Johnson•7h ago

United StatesRemoteFull-timeSenior Level8+ yrs exp

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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
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 is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource. 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

Required skills

QualityRegulatory AffairsComplianceProject ManagementLeanSix SigmaMedical Device RegulationsISO 13485