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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-367659 Date posted 06/30/2020

Job Description Summary

The Director of Regulatory Compliance is responsible for working with all designated sites worldwide on various regulatory compliance issues as well as working across the business leading major projects and initiatives. This position reports directly to the Sr. Director, Regulatory Compliance.

The position is accountable for the development and execution of strategies and plans to meet key operational goals. Assumes critical leadership role in key projects. Erroneous decisions could result in significant regulatory risk and regulatory action taken against BD.

Job Description

Regulatory Compliance activities, including:

  • Maintains compliance metrics, and, in conjunction with Unit Quality Management, uses these metrics to improve processes, efficiency, and the quality of products and systems.
  • Oversees all recall or other compliance related customer notification activities including reports of such actions to regulators.  Ensures timely decision-making and actions.  The responsibility for the conduct of such compliance actions may be delegated to RC Managers within the units.
  • Facilitates the Field Action process for designated business units to assure BD addresses product quality issues that may result in a field action. 
  • Collaborates on the development of the Situation Analysis (SA) and Health Hazard Evaluation(HHE), as required.   SA’s and HHE’s serve as the key inputs to the FAC process and are critical to making sound decisions relating to the quality issues and actions to be taken related to product in the field.
  • Collaborates with leadership in Quality and Medical Affairs on the development and approval of the Field Action decision.
  • Manages and/or executes Product Recalls and Field Safety Corrective Action Notices with Customers, Dealers, and regional regulatory representatives.
  • Communicates with the FDA regarding field actions, as needed.
  • In conjunction with Unit Quality Management, participates in management reviews of Quality Systems for Segments and/or Units. Assures management is adequately informed of opportunities for improvement and helps develop strategic and tactical plans for same, including the identification of resource requirements to accomplish tasks within appropriate time periods.
  • Works closely with the Complaint Management Centers to assure BD remains compliant with US and other International Adverse Event Reporting activities.
  • Responds to and maintains communications with the FDA on MDR trends, FDA Inspections, 483 Responses, and other communication topics, as needed.
  • Actively participates in FDA Inspections; both pre-inspection activities, inspection management, and BD 483 Responses.
  • Provides support service for BD legal in response to litigation as requested
  • Works with BD Corporate RA/RC to define and manage policies and procedures for the WW businesses relative to adverse event reports, the management of product recalls and notifications, and responses to inquiries by regulators or other governmental bodies.
  • In conjunction with Regulatory Affairs, collects information on new and evolving regulations, guidances, and policies associated with FDA, other US government Agencies regulating health care products and international regulatory agencies or their equivalents.  Analyzes and disseminates this information and provides training on those issues relevant to BD.
  • Manages compliance staff for assigned business responsibilities.

Qualifications

  • B.A. or B.S. in the life sciences or engineering; Advanced degree desirable
  • Experience in the medical device, pharmaceutical or biologics industries with specific experience in regulatory compliance, quality systems, audits / inspections, and adverse event reporting
  • Strong experience in US and EU regulatory systems and practices
  • Knowledge of fraud and abuse regulations
  • Experience in coaching, development, and management of staff
  • Excellent verbal and written communications skills
  • Ability to work in a team environment
  • Six Sigma experience preferred

#LI_EXEC

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA MD - Baltimore

Work Shift

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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