Global UDI
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Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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.
Job Function:
Project/Program Management GroupJob Sub Function:
Project/Program ManagementJob Category:
ProfessionalAll Job Posting Locations:
Ringaskiddy Cork IrelandJob Description:
DePuy Synthes is recruiting for a(n) Global UDI this Hybrid positionwill be in Raynham Massachusetts. Alternate Hybrid locations may be considered at Loughbeg Ringaskiddy
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):
Loughbeg Ringaskiddy - Requisition Number: 081287
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
The Global UDI role plays a critical part inensuringDePuy Synthes global compliance with Unique Device Identification (UDI) regulatory requirements through robust quality oversight of enabling technologies systems and processes. This position partnerscrossfunctionallywith Regulatory Affairs IT Supply Chain and Manufacturing to ensure UDI data accuracy system validation and sustained compliance across global markets. The role offers high visibility global impact and the opportunity to influenceenterpriselevelquality and digital transformation initiatives supporting patient safety and regulatory excellence.
Key Responsibilities
Provideoversightfor global UDI technology platforms data flows and supporting systems to ensure regulatory compliance and data integrity.
Support development implementation and maintenance ofUDIrelatedquality processes procedures and controls across the product lifecycle.
Partner with IT and business stakeholders to ensure UDI systems arevalidated maintained and compliant with applicable quality system regulations.
Review and approveUDIrelateddocumentation including system validation deliverables change controls risk assessments and procedural updates.
Monitor and assess UDI data accuracy completeness and timeliness across internal systems and external regulatory databases.
Support internal and external audits inspections and health authority interactions related to UDI and supporting technologies.
Identifyquality risks trends and improvement opportunities related to UDI processes and digital solutions; drive corrective and preventive actions.
Provide quality guidance and training tocrossfunctionalpartners on UDI requirements quality standards and system controls.
Qualifications
Education
Required:Bachelors degree in Engineering Computer Science Information Systems Life Sciences ora relateddiscipline.
Preferred: Advanced degree in Quality Regulatory ora technicalfield.
Experience and Skills
Required:
Typically48 years of experience in Quality Assurance Quality Systems orRegulatoryadjacentroles within medical devices pharmaceuticals or regulated industries.
Experience supporting validated systems and technology platforms in a regulated environment.
Working knowledge of global UDI regulations (e.g. FDA EU MDR) and quality system requirements.
Experience with change control risk management and documentation review within a quality framework.
Demonstrated ability to analyze quality dataidentifytrends and drive continuous improvement.
Preferred:
Experience with UDI databases labeling systems or enterprise data management platforms.
Familiarity with computer system validation (CSV) and digital quality controls.
Experience supporting regulatory inspections or audits related to data integrity or digital systems.
Knowledge of Lean Six Sigma or continuous improvement methodologies.
Experience working in a global or matrixed organization.
Strong collaboration skills with the ability to work effectively across globalcrossfunctionalteams.
Other:
Language: Englishproficiency.
Travel: Up to 1015% domestic and occasional international.
Certifications: ASQ certifications (e.g. CQA CQE) or similar quality certifications preferred.
For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit
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 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.
Required Skills:
Preferred Skills:
Agility Jumps Analytics Insights Business Alignment Business Behavior Collaboration Tools Communication Cost-Benefit Analysis (CBA) Data Analysis Monitoring Evaluation and Learning (MEL) Problem Solving Process Oriented Project Management Methodology (PMM) Project Management Office (PMO) Project Reporting Project Support Statement of Work (SOW) Time ManagementThe anticipated base pay range for this position is:
52400.00 - 82915.00Benefits:
In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
