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BD (Becton, Dickinson and Company) Global UDI Process Manager in Sandy, Utah

Job Description SummaryBD’s Global UDI Process Manager will provide support/subject matter expertise and lead components of the overall execution and maintenance of the Unique Device Identification (UDI) Program.

This role will support and execute the various UDI related projects across BD’s nine (9) Business Units, multiple countries, and various functions. Additionally, this role will be responsible for the creation and maintenance of new policies, procedures, and processes to implement global UDI regulations and associated market requirements. This individual will provide subject matter expertise to guide and support the various implementation activities across BD. This role will help assess a complex set of rules, implementation dates, customer requirements and translate them into easy-to-understand information to guide a variety of associates world-wide in their implementation activities.

This individual will support the Business Units, Countries, and Functions as they implement UDI requirements simultaneously in multiple countries with varying due dates and, at times, conflicting regulations and requirements that continue to evolve. This support includes explaining the requirements, verifying adherence, answering questions, providing interpretations, and other support. Additional responsibilities will include utilizing problem-solving skills to assess adherence to requirements, monitor performance, and create/deliver training material.

This position requires an individual that can manage details, document complex requirements, understand business processes, and can take responsibility for continued self-learning and subject matter expertise. This person must also have a demonstrated ability to engage BD associates, at the “how to” level, and to help them achieve a successful implementation.

Job Description

Responsibilities:

  • Apply extensive technical expertise and knowledge on UDI regulations, data standards. knowledge and market requirements towards achieving the implementation of UDI.

  • Own and execute some of the deliverables identified in the project plan.

  • Provide specific UDI, regulatory, and data standards subject matter expertise. Be responsible for updates, communication, tools, and guidance needed to support the businesses, regions, and functions.

  • Assist in the creation of tools, training material, work instructions, and general communications needed to help drive the overall success of the program.

  • Develop technical and business process solutions that are critical to the success of UDI and associated data requirements.

  • Helps identify data and/or label quality or compliance risks and resolve/escalate as appropriate.

  • Interact with the PIM team as a data curator to align all data attributes globally.

Essential Job Functions:

The following duties and responsibilities are intended to be representative of the work performed by the individual in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

  • Responsible for assisting in the creation and maintenance of UDI policies and procedures.

  • Integrate and align BD’s overall UDI policies as part of our overall Quality initiative.

  • Support the BUs as they align their procedures with the overall UDI policies and procedures.

  • Create and deliver UDI training materials.

  • Provide day-to-day subject matter expertise to the Business Units, Functions, and Countries.

  • Provide support for general UDI questions.

  • Create BUDI assignments.

  • Aid in the curator role for our overall UDI data dictionary.

  • Align requirements with the countries, regions, and functions as needed.

  • Support the resolution of data and bar code errors.

  • Support the integration and alignment of PIM with our overall UDI efforts.

Basic Qualifications:

  • Prior experience implementing Unique Device Identification requirements.

  • The ability to function effectively and achieve results in a large matrix organization.

  • Excellent analytical and problem-solving skills.

  • Strong written and verbal communication skills.

  • Experienced in business processes to support training and business administration.

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

Education and/or Experience:

  • Bachelor’s degree preferred.

  • Prior experience in Life sciences industry (Pharmaceutical, Medical Device, or Bio-Tech).

  • Three or more years of experience in Regulatory, Quality, Operations, or R&D.

  • Knowledge of the European Medical Device Regulation (EU MDR) EUDAMED, U.S. FDA GUDID, and/or Global UDI Regulations preferred.

  • Experience writing and implementing policies and procedures.

  • Knowledge of Medical Device and IVD development process as well as product life cycle maintenance.

  • Experience creating and delivering training materials is preferred.

  • Project Management Professional Certification (PMP) is preferred.

  • Lean Six Sigma Certification (Green Belt) preferred.

Physical Demands:

Use of computer, phone, ability to travel both domestic and globally up to 10% of the time.

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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Primary Work LocationUSA NJ - Franklin Lakes

Additional LocationsUSA AZ - Tempe BPV Building 1, USA CA - San Diego Bldg A&B, USA GA - Covington BMD, USA IL - Vernon Hills, USA MD - Sparks - 26 Loveton Circle, USA RI - Warwick, USA UT - Sandy

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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