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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-363925 Date posted 03/25/2020

Job Description Summary

Job Description

Reporting to the Vice President, Regulatory Affairs. Responsible for creating and executing regulatory strategies and objectives for pre-market programs in alignment with business needs.These regulatory strategies may influence the scientific or technical direction of product design and/or development. The Director Regulatory Affairs is responsible for managing RA associates, for ensuring functional excellence, and for establishing collaborative relationships with other functional leaders.

RESPONSIBILITIES

  • Provides regulatory leadership for programs in the pre-market space for the MMS Regulatory Team
  • Works with the worldwide MMS LT members to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans
  • Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other regulatory bodies
  • Prepares, or directs the preparation of global regulatory submissions.
  • Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders
  • Directs the preparation of product information for product registrations
  • Monitors Worldwide regulatory developments affecting the Business Group’s Platforms and Programs and communicates emerging opportunities and concerns to stakeholders
  • Represents MMS in interactions/negotiations with global U.S. regulatory agencies and Notified Bodies; enables / empowers staff to interact and negotiate with regulators
  • Participates in Public Policy and Advocacy efforts in support of the strategic direction
  • Represents MMS in external activities benefiting BD  including trade associations, professional organizations, and standards development organizations
  • Manages a staff of regulatory professionals carrying out product submission/registration activities.  Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives
  • Develops direct reports required competencies, including, but not limited to, regulatory knowledge and ability to apply and communicate this knowledge
  • Conducts training on regulatory issues for staff and for business stakeholders (e.g., Clinical, R&D., Marketing)
  • Reviews and approves labels, labeling, promotional materials, clinical protocols, and clinical reports
  • Plans departmental budget for MMS Regulatory Affairs

REQUIREMENTS

  • B.S. or B.A. degree in a technical discipline (e.g., engineering, biology, chemistry).  Advanced degree preferred.
  • RAPS Certification preferred
  • Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields and two years of management experience
  • Experience with Medical devices, pumping systems and electromechanical devices preferred.
  • Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
  • Experience in negotiating with FDA personnel in CDRH .
  • Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies.
  • Demonstrated leadership skills.
  • Demonstrated project management, negotiation, and communication (written and oral) skills.
  • Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
  • Comprehensive knowledge of U.S. medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.
  • Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDMDD 98/79/EC.

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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