Senior Counsel - Regulatory

BD (Becton, Dickinson And Company) Franklin Lakes , NJ 07417

Posted 6 days ago

Job Description: SummaryThe successful candidate will be a core member of BD's legal team helping drive the Company's mission, protecting the Company, and serving as a trusted advisor and strategic leader within the department and the Company. S/he will provide both strategic and tactical support and will serve as a strategic legal partner to BD's Regulatory and Quality teams. S/he must have the ability and desire to serve as a recognized thought leader within and outside of BD in the legal and regulatory arenas.

This is a unique opportunity for an individual to serve as a trusted advisor and commercially astute business partner who will collaborate effectively across the Company to assist the Company in meeting business objectives while ensuring regulatory compliance and mitigating risk. The position requires an expert level of understanding of legal-regulatory implications of business decisions enterprise-wide and will play a significant role in enabling the Company and its professionals to deliver services effectively and efficiently, while appropriately managing risks in the heavily regulated environments in which the Company operates. S/he is ultimately responsible for facilitating the business objectives of the Company by providing timely and effective legal support, as well as minimizing potential legal exposure and risk. The successful candidate will be a "hands-on" attorney who is able to run autonomously yet operate in a global business.

This position has direct client contact at the business unit leadership level and the corporate senior leadership level. The successful candidate will have the opportunity to make an immediate contribution to BD's continuing growth and success. The person sought for this role will be a proven, high potential candidate with strong intellectual and technical skills and successor qualities and attributes.

Job Description

  • Provide legal counsel to clients throughout the organization on a variety of regulatory and quality matters, including pre-market approval and post-market surveillance, as well as product issues and other business matters. Provide expert advice and counsel to businesses concerning complex regulatory matters and issues germane to the business with a focus on FDA issues enterprise wide. Primary clients include Regulatory, Quality, Sales and Marketing, R&D, and Medical Affairs.

  • Provide legal counsel during regulatory agency investigations and/or administrative actions brought against the Company with particular emphasis on FDA issues

  • Ensure high quality legal advice is provided to business clients; proactively identify trends (legal/business); participate as a strategic partner with client groups and stakeholders.

  • Maintain knowledge of FDA law and regulation changes and enforcement actions in order to maintain the highest level of expertise

  • Proactively advise on legal risks related to business activities, develop solutions to mitigate risk and influence key business leaders.

  • Support regulatory due diligence for new business and product acquisitions.

  • Manage activity and reporting required by an existing consent decree.

  • Provide day to day legal advice and oversight to a variety of constituents including management, customers and governmental officials on a range of regulatory matters.

  • Understand and be able to translate into "plain English" the legal ramifications of varied legal and regulatory and clearly and succinctly articulate the risks.

  • Support Quality and Regulatory Affairs with the development of policies, procedures, and training programs to ensure that FDA regulations and other regulatory best practices are reflected in the Company's business activities.

  • Assure proper resource planning and manage outside counsel.

  • Work closely with the Ethics and Compliance department.

Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

Work Shift


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Global Regulatory Operations Project Specialist

BD (Becton, Dickinson And Company)

Posted 7 days ago

VIEW JOBS 3/13/2019 12:00:00 AM 2019-06-11T00:00 Job Description Summary Job Description The Global Regulatory Operations, Project Specialist, manages and executes EU MDR/IVDR Workstreams that support Global Regulatory Affairs. This is an assignment position that will begin February 2019 and ends on or before September 2022. This position does not provide relocation assistance. Essential Job Functions: The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position. * Serves as part of the corporate Regulatory Operations team that drives the strategy for labeling support. * Skilled at technology such as Sharepoint, Excel, power point, intranet sites. * Able to assess processes to recommend and drive to efficient future state processes including gaining buy in for key stakeholders * Assess and provide recommendations of best practices between business units and drive to standardization of processes where possible. * Lead updates of communications including metrics, newsletters, town halls, and other key communications. * Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures where appropriate. * Assist with additional regulatory projects as needed. Responsibilities: * Support the EU MDR/IVDR labeling work based on guidance from workstream leader. * Provide subject matter expertise to support BU specific requests per the program deliverables. * Lead and assess global labeling requirements to establish a labeling strategy for re-registrations and labeling activities * Determine 'best and worst' case labeling scenarios with the BUs to highlight potential program risks. * Lead change management and deployment of BDX symbols including website tool deployment for BU ongoing usage * Identification of labeling process improvement opportunities related to change control, translations and other RA specific processes * Leverage basic Project Management skills such as: * Work breakdown activity and milestone creation * Schedule and dependency management * Scope identification and mechanisms for control * Understanding budgeting principles to associate work effort to resource needs * Meeting management execution * Support program team with status reporting, metrics, and overall data collection activities for leadership visibility * Establish a process for managing updates to global requirements to evaluate impacts to procedures and systems impacted Basic Qualifications: * Strong leadership and influence management skills and the ability to function effectively in large matrix organizations. * Excellent analytical and problem solving skills * Sound working knowledge of the Global regulatory environment * Ability to effectively communicate complex issues and programs to all levels of the organization. * Excellent experience and knowledge of PC/database skills * Experience and knowledge of labeling processes and systems Leadership: * Proven ability to earn the trust of leaders within the organization, including senior leaders * Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives * Proven ability to resolve conflict (striving for win-win outcomes) * Proven ability to deliver tough messages in a professional manner * Proven ability to act independently and to execute with limited information and ambiguity Education and Requirements: * 5+ years of related industry experience required * Working knowledge of Medical Device and IVD labeling development and approval process as well as life cycle maintenance required * Proven project management experience (this individual will be required to manage multiple projects simultaneously), Project Management certification (PMP) preferred * Experience implementing electronic labeling solutions strongly preferred * Experience implementing EU MDR / IVDR labeling changes strongly preferred * Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency * Strong interpersonal skills with the ability to influence others in a positive and effective manner * Ability to work in a team environment * Excellent communication skills; both oral and written * Planning and time management skills, including a demonstrated ability to organize work and establish priorities. Primary Work LocationUSA NJ - Franklin Lakes Additional Locations Work Shift BD (Becton, Dickinson And Company) Franklin Lakes NJ

Senior Counsel - Regulatory

BD (Becton, Dickinson And Company)