BD (Becton, Dickinson and Company) Senior Manager UDI Compliance in Franklin Lakes, New Jersey
Job Description SummaryUnder the direction of the Unique Device Identification (UDI) Program Office, the Senior Manager UDI Compliance will help monitor, interpret, align, document, and execute BD’s program for meeting UDI requirements globally. The interpretation of UDI regulations will consider customer requirements, internal process needs, and the global distribution of our products. This individual will help to train and liaise with the applicable business units and functions to guide proper execution of various product identification processes. This individual will also aid in the overall implementation and execution of BD’s global UDI program as needed.
Help create policies and documentation to guide BD’s global UDI implementation. For example:
Device identification enumeration practices
Standard Operating Procedures for UDI label changes
Coach and guide the businesses with the regulatory adherence of their UDI implementation programs.
Manage exceptions and accepted deviations to BD’s internal requirements
Create specifications for BD’s outside suppliers to implement UDI
Monitor and assist in the interpretation and development of UDI related regulations globally. To include:
Develop tools, systems, or analytics to aid in the implementation and/or monitoring of the program
Assist in the review of customer and/or distribution center information on barcode or data errors
Work with Quality to support the creation of an Audit Procedure
Support the business platforms in adhering to UDI requirements
Assist in the creation of analytics and the overall execution of UDI
Gather, compare, analyze product registration data for applicable countries to help scope the UDI initiative
Track and evaluate progress
Help the business platforms identify when to seek a global UDI template and when deviation is required to meet local requirements
Assist in the execution of UDI, including support for:
UDI Regulations for medical devices
NDC and other adjacent product enumeration requirements
Healthcare provider generated UDI requirements
BD internal device identification requirements
•Knowledge and experience with the documentation of control processes including DHF requirements
•Must be familiar with medical device label creation and modification processes
•Familiarity with GS1 General Specifications and supply chain usage of GS1 data standards is a plus
•Some experience in the creation of corporate policies, procedures, SOPs, or associated documentation.
•Previous experience interpreting and implementing FDA’s UDI Regulation is a plus
•Experience using SAP, TrackWise, PIM Systems, and other applicable systems is highly desired
B.S., B.A., or comparable college degree
Three plus years of regulatory experience. At least three to five years of related experience in Operations/Engineering/Quality or similar experience.
•Must be able to work effectively across segments, platforms, regions, and manufacturing sites; and possess a high degree of integrity, good judgment, assertiveness, an approachable demeanor, and the ability to elicit the respect and trust of BD associates.
•Excellent analytical and written/verbal communication skills
Primary Work LocationUSA NJ - Franklin Lakes
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