Job Description Summary

The UDI Compliance Project Manager (PM) will track, monitor, and support the progress of Business units in their ongoing implementation plans to meet UDI regulations and specific related market requirements for UDI labeling and data compliance. The role will liaise with Operations, Quality, Regulatory Affairs, the Master Data Organization, and other functions to ensure that UDI labeling compliance is tracked and reported, and that accurate UDI data is provided to multiple regulatory databases.

In addition, the UDI Compliance PM will support data gathering and validation initiatives, publication of data to UDI data bases, and maintenance of master data for UDI. This individual will utilize various systems including SAP, JDE, Master Data Control, Product Labels, Technical Files, and other data sources to support compliance with UDI regulations around the world.

This position requires an individual that can manage details, genuinely enjoys working with data, and can work independently to implement a precise set of requirements. This individual must also have a demonstrated ability to manage projects, have experience with various ERP and other systems and have strong technical skills.

Job Description

Remote

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Functional/Organizational Summary

Under the direction of Corporate Regulatory this position will be working directly with several BD Business Units.  The Business Unit teams will include Regulatory Affairs, R&D, Operations, and Quality.  It is also expected that there will interactions with Corporate Supply Chain and Corporate Quality. 

Responsibilities:

• Communicate with Business Units regarding UDI data collection and labeling compliance due dates and track progress to and through completion.

• Create and maintain reports and metrics for UDI labeling and data compliance.

• Publish data to various global systems.

• Gather UDI and associated master data for the use in variety of systems globally.

• Verify that existing master data is aligned with source data.  Sources to include SAP, Product Labels, Technical Files, etc.

• Liaise with an existing Business Unit team to resolve data discrepancies.

• Support other project planning, data requirements, and ad hoc reporting, as needed.

Basic Qualifications:

• Project management skills

• Excellent analytical and data management skills

• Ability to work independently with guidance from an existing Business Unit team

• Ability to effectively communicate complex issues to all levels of the organization.

Education and/or Experience:

• Must be adept utilizing Excel, Access, MS Project and other data tools

• Demonstrated ability working with product master data

• Bachelor’s degree is desired

• Previous Regulatory, Quality, or Operations experience is highly desired

• Experience using SAP, JDE, TrackWise, Master Control, WMS systems, Product Technical Files, and Labeling Systems is highly desired.

• Prior experience implementing Unique Device Identification for the FDA GUDID system, EUDAMED, or other UDI systems is highly desired

• Project Management Professional (PMO) certification is a plus

Physical Demands:

Use of computer and phone.

Work Environment:

Office and remote locations

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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R-435245

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift