Job ID R-374804 Date posted 10/07/2020

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.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
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Responsibilities

Job Description Summary

Job Description

The Manager of Regulatory Policy will play a critical role in interpreting and influencing the US regulatory environment to contribute to BD’s mission.  The Manager will provide support to advance BD’s positions on US FDA regulatory policy and legislative issues.  As a member of the Public Affairs team, the Manager will also support BD’s advocacy efforts in an evolving regulatory environment on behalf of patients and providers to ensure access to BD’s best-in-class products.  This position will support the Director, Regulatory Policy in influencing strategies needed to achieve Corporate Regulatory goals identified as supporting KDGs for individual businesses and/or BDX overall.

Responsibilities

  • Monitors US FDA regulatory policy and legislative topics of interest to BD, supports internal monitoring and communication processes regarding US FDA regulatory environment, and supports coordination with business units’ regulatory affairs teams in developing and submitting BD comments on US FDA regulatory policy.

  • Develops and maintains an awareness of the evolving internal and external regulatory needs and requirements; works collaboratively with both internal and external stakeholders to influence the regulatory policy environment.

  • Represents BD in industry working groups as assigned to support regulatory policy and legislative proposals that align with BD strategic interests in pre- and post-market regulation of medical technology; summarizes and communicates policy meetings and events; plans and manages interactions and communications with trade associations on regulatory policy matters.

  • Consults with internal experts and leadership to identify priority issues; prepares and delivers regulatory intelligence alerts, summaries, reports, and newsletters on regular schedule highlighting pertinent regulatory and legislative activities and potential impact on BDX products and businesses.

  • Remains current on legislation, US FDA regulations, and guidance documents related to BD products and keeps an open line of communication to key stakeholders including interactions with US FDA.

  • Assist with additional regulatory projects as assigned.  

Qualifications

  • Bachelor's degree required in a technical discipline, with a minimum of 3 years of related professional experience; advanced degree desirable

  • Strong working knowledge and experience with current FDA medical device regulatory requirements

  • Ability to organize diverse projects in a timely manner

  • Working knowledge of electronic documentation and information systems

  • Strong background and history of managing projects with proven track record of successful outcomes

  • Excellent interpersonal, oral and written communication skills with the ability to work effectively with members of cross-functional teams

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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USA DC - Washington, DC

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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

Advancing the world of health™

BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.


Brian Carney
Staff Regulatory Affairs 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.


Robin Cassell
Global Regulatory Operations Labeling Specialist

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.


Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist

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