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Overview

Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health. At BD, you can make a true difference of one.

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Success Profile

What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Analytical
  • Collaborative
  • Communicator
  • Persuasive
  • Problem-solver
  • Skilled presenter

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A New Era in Healthcare

The complementary nature of BD and CareFusion capabilities make the new, combined company more relevant than ever before. It’s not just the solutions we offer, It’s also where we offer them. The global reach of the combined company can offer new solutions around the world.

Quote

Brian Carney, Staff RA Specialist, BD, Surgical

"The team at BD was exceptionally welcoming and courteous upon arrival on my first day. I was immensely impressed with the passion of my project team members. Positive energy here is contagious… I very much look forward to the coming years with the BD team!"

Robin Cassell, Global Regulatory Operations Labeling Specialist

"I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job."

Nikita A Mahendra Kumar, Senior Regulatory Affairs Specialist, Medication Delivery Solutions

"I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on."

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Benefits

  • Healthcare

  • Healthcare FSA

  • 401(k) / Retirement Plans

  • Employer Matching

  • Tutition Reimbursement

  • Paid Time Off

  • Location

  • Collaborative Culture

  • Compensation

  • Awards & Recognition

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Responsibilities

Job ID R-368272 Date posted 07/03/2020

Job Description Summary

Job Description

The Labeling Program Manager is responsible for managing the creation, approval, implementation and maintenance of technical information for products manufactured by applicable BD sites.  This includes developing and maintaining content and graphic standards as proposed by corporate, regulatory, safety, legal and global guidelines. The Program Manager serves as a champion of best practices and continuous improvement and participates, and sometimes leads, business and corporate-wide initiatives.  The Program Manager is accountable for the development and execution of strategies and plans to meet key operational goals. This leadership role is responsible for positive customer experiences as it relates to the global product information. Error in this information could result in a significant budgetary impact as well as regulatory risk and subsequent action against BD worldwide.

Job Responsibilities:

  • Develops, revises and reviews product package labeling, carton labels, and component labels to ensure compliance to global regulations.
  • Analyzes product specifications and oversees development of documentation which may include manuals, reagent package inserts, and labels for sustaining products
  • Ensures accuracy, clarity, appropriateness, and consistency of documents; reviews and may evaluate documents of other writers when appropriate.  
  • Serves as a resource to writers and label designers in areas of content development and label design.
  • Follows logical, structured, and consistent thought processes when planning, speaking, and presenting in meetings.
  • Possesses ability to organize information into a clear and logical sequence.
  • Performs gap analysis and make suggestions for improvements to processes and procedures.
  • Manages workload, timeline and resources for a project. Informs team early about possible issues. Plans and prepare for possible issues and formulate a mitigation plan.
  • Has the ability to craft and deliver explanations that anticipate customers’ questions and solve customers’ problems.
  • Serves as a subject matter expert for product labels/inserts and/or instrument user's manuals.
  • Works with R&D, Marketing, Quality, Medical, Regulatory and plant teams and associates to develop/revise product labeling, user documentation and determine specifications for: type style, font size, clarity and conformity of wording, formatting and print/digital delivery.
  • Assists with the development and implementation of packaging and labeling processes for BD plants.
  • Works with Label Control, Incoming Inspection, Operations and Quality to resolve quality issues regarding labeling, and developing internal and external procedures geared toward minimizing and eliminating labelling recalls.
  • Develops, reviews and maintains vendor specifications, graphic and labeling standards.
  • Develops procedures and policies to streamline the labeling design/development process.
  • Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business units and plant projects to meet established goals.
  • Keep abreast of and comply with the basic requirements for compliance in own area of work. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.

Minimum Qualifications:

Education and Experience:

  • BS or BA degree in a technical, scientific, packaging, writing or related discipline.
  • Minimum of 5 years' experience in medical device labeling required.
  • Experience with DTP application experience (Adobe products and/or MadCap Flare) highly preferred.
  • Experience working on international cross-functional teams.
  • Working knowledge of US and international medical device regulations.
  • Demonstrated ability to influence others (beyond direct reports).
  • Demonstrated ability to effectively handle multiple project priorities.
  • Excellent organization & prioritization skills.
  • Excellent follow-up and documentation skills.
  • Willingness to travel up to 15%.

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.

#LI-TECH

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift

Apply Now

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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, 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