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.

Job Description

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:

  • Regulations

  • Market Requirements

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

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

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Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

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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