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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-358869 Date posted 02/04/2020

Job Description Summary

Job Description

Reporting to the International Regulatory Affairs Senior Manager, this people manager role supports the regulatory registration of Integrated Diagnostic Solutions (‘IDS’) Specimen Management (‘SM’) products worldwide.  Contributes to Global Product Development System (GPDS) Business Plans by assessing regulatory requirements in various international markets for products under development.  Such assessments may influence decisions on where and when to launch new products.  Collaborates with associates outside the US to achieve rapid worldwide registration of IDS SM products by providing all documents needs for such efforts.  Supports continued registration of marketed products on a worldwide basis.  Standardizes processes and procedures throughout all of IDS SM International Regulatory Affairs and works with Corporate International Affairs on process improvements to streamline registration request completion.

Responsibilities:

  • Establishes strategy and manages international registration activities for IDS  International markets for products under development.
  • Collaborates with worldwide Regulatory Affairs and Business Leads to achieve rapid worldwide registrations.
  • Supports continued registration of marketed products on a worldwide basis.
  • Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders.
  • Participates in interactions/negotiations with ex-US. Regulatory agencies when needed.
  • Directs one or more associates or contractors to handle registration requests and associated documentation.
  • Monitors regulatory developments affecting IDS products and communicates emerging opportunities and concerns to stakeholders, including those on product development teams.
  • Designs and implements training on international registration issues for the RA function and for business stake holders (e.g., Marketing, Sales, Medical Affairs, and R&D).
  • Represents IDS in external activities, including trade associations and professional organizations. 
  • Identifies and implements improvements in product registration processes and standardizes processes throughout all of IDS International Regulatory Affairs.
  • Participates in one or more corporate-wide workgroups to address specific international registration issues.
  • Interprets ex-US regulations and guidance documents and is able to communicate impact back to the business.
  • Manages the iRAOP for IDS including the coordination and chairing of iRAOP calls with the regions and countries.

Manages and coordinates the electronic Global Product Submission (eGPS) database with an in depth understanding of advanced technical/scientific principles that relate to multiple diverse and complex product lines or manufacturing processes to: 

  • Ensure that the most recent, reliable source documents for product registrations are linked, scanned and/or uploaded into the database
  • Respond to and track the additional information requests (AIRs) submitted by the international regional RA partners
  • Provide training as a Super User
  • Develops and maintains departmental procedures (SOPs & Work Instructions) for international product registrations.
  • Identifies and implement continuous process improvements
  • Independently coordinatse and collecst specific registration information with R&D, Manufacturing, QA, Medical Affairs, and other applicable departments as necessary. Coordinate timely preparation of request for Certificates for Foreign Government, Certificates of Manufacturing and Free Sales, and Certificates for Exportability. Monitoring and collecting/compiling the impact assessments of product changes (ACRs) for outside the US.
  • Carries out the above tasks with minimal supervision.

Requirements

  • B.S. degree or higher in a technical discipline, preferable in engineering, bioengineering, biology, chemistry, or computer science.
  • 3-5+ years Regulatory Affairs experience in medical device companies, preferably including experience in Regulatory Affairs related to in vitro diagnostic devices.
  • People Managerial experience is required.
  • Experience supporting product development and/or product support projects.
  • Demonstrated ability to effectively communicate both verbally and in writing.
  • Successful history of handling multiple projects, and prioritize activities and managing deadlines.
  • Experience maintaining confidential information at appropriate levels within an organization.

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

US BD 1st Shift 830am-5pm (United States of America)
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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