Assistant General Counsel, Regulatory Law

Becton, Dickinson and Company • Franklin Lakes, NJ, United States • $200k - $250k / year • 1m ago

Job Description Summary

The Assistant General Counsel, Regulatory Law will be a member of the Regulatory Law Group and will report to the VP Compliance Officer and Chief Regulatory Counsel.

Partnering with multiple BD Business Units, he/she will be responsible for providing regulatory law advice and counsel on a wide range of matters. The successful candidate will be a core member of BD’s regulatory legal team helping drive the Company’s mission, protecting the Company, and serving as a trusted advisor within the department and supported businesses. S/he will provide both strategic and tactical support and will serve as a strategic legal partner to BD’s Regulatory, Quality, Medical Affairs, Sales and Marketing, and Product Development teams.

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 supported businesses in meeting business objectives while ensuring regulatory compliance and mitigating risk. The position requires a superior understanding of legal and regulatory implications of business decisions 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 providing timely and effective legal support in the supported business. The successful candidate will be a “hands-on” attorney who is able to operate with minimal oversight and effectively collaborate across a matrixed organization.

This position has direct client contact at the business unit 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, technical and people skills.

Responsibilities:

Provide legal counsel to clients on a variety of regulatory and quality matters, including pre-market approval and post-market surveillance, promotional issues, product development issues and other regulatory matters.
Provide expert advice and counsel to supported businesses concerning complex regulatory matters with a focus on FDA and equivalent regulatory authority issues and compliance risks.
Provide legal counsel during regulatory agency investigations and/or administrative actions brought against the Company with particular emphasis on FDA regulatory 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 changes to relevant laws and regulations, as well as updated knowledge of government enforcement actions to maintain the highest level of expertise.
Proactively advise and train the supported businesses on 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.
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.
Ensure proper resource planning and manage outside counsel.

Qualifications:

The successful candidate will hold a law degree with strong academic credentials from an accredited law school and will have obtained an undergraduate degree from a college or university of recognized standing.
Be licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States without any instances of suspension, revocation, censure or other adverse events in any jurisdiction.
8+ years of relevant medical device regulatory law experience.
Ability to effectively communicate with and influence a wide spectrum of individuals: from government officials, to attorneys, executives, associates and agents.
Practiced at a well-respected law firm combined with having served in an in-house or FDA or other government regulatory role.
Significant experience in FDA and other regulatory issues specifically related to medical devices and/or diagnostics throughout the lifecycle of the product, including development, approval and marketing.
Deep understanding of the regulatory and submission requirements, particularly with respect to implanted medical devices, diagnostics, home-use medical devices, and durable medical equipment.
Experience supporting RA and Quality leaders in navigating interactions with FDA and other regulators in a positive and collaborative manner during inspections, requests for additional information, recall activities, complaint handling, and throughout the submissions process.
Experience advising clients relating to Quality System regulations, Good Manufacturing Practices (GMPs), EU Drug Safety/Pharmacovigilance, and clinical trials preferred.
Expertise with fraud and abuse laws such as the U.S. Anti-Kickback Statute, Foreign Corrupt Practices Act, and industry codes, such as the AdvaMed Code of Ethics preferred.
Knowledge of global privacy and data protection laws such as HIPAA and GDPR is a plus, but not required.
Demonstrated ability to lead through influence and navigate controversial situations and negotiations.
A commercially oriented attorney with strong strategic, commercial and interpersonal skills who understands the nuances of complicated regulatory issues and is well able to think creatively to problem solve and mitigate risk while supporting business objectives.
Ability to contemplate the legal implications of new innovations and collaborate with the business to develop regulatory strategies for new technologies.
Superior writing skills with an ability to present nuanced, complicated, and content rich issues clearly.
Demonstrated ability to exercise independent judgment effectively.
Ability to draft and implement key corporate policies and procedures to empower and enable associates to achieve business objectives in a compliant manner.
Tech savvy with excellent presentation and people skills.