Job Description Summary
The Associate General Counsel, Regulatory Law and Compliance will be a member of the Regulatory Law Group and will report to the VP Compliance Officer and Chief Regulatory Counsel.
Partnering primarily with BD’s Global Medication Management Solutions business unit, one other business unit, and Corporate Quality Assurance team, he/she will be responsible for providing regulatory law advice and counsel on a wide range of regulatory and compliance matters, with a particular focus on post-market quality system compliance. This attorney 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. 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 Company.
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 their 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 products and services effectively and efficiently, while appropriately managing risks in the heavily regulated environments in which the Company operates. 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 excellent judgment, 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, with a focus on quality system compliance, recalls, and responding to government enforcement actions.
- Implement BD’s healthcare compliance program at one business unit and serve as a member of the BU Leadership Team.
- Provide legal advice related to and manage compliance requirements for an existing Consent Decree.
- Provide legal counsel during regulatory agency investigations and/or administrative actions brought against the Company with particular emphasis on FDA regulatory issues.
- Maintain knowledge of key legal and regulatory changes and enforcement actions in order to maintain the highest level of expertise.
- Support global regulatory and quality integration activities for a new business unit business.
- Support due diligence for future business and product acquisitions.
- Understand and be able to translate into “plain English” the legal ramifications of varied legal and regulatory issues, clearly and succinctly articulate the risks and offer potential solutions.
- Develop strong relationships throughout all functional areas, departments and divisions to foster an advisory and collaborative approach to proactive compliance.
- Proactively advise and train clients on legal risks related to business activities, develop solutions to mitigate risk and influence key business leaders.
- Facilitate Compliance Committee meetings for the supported business unit(s).
- Acquire, develop, and present relevant compliance metrics for internal audiences within supported business unit(s).
- Conduct, delegate, manage and resolve compliance investigations, as necessary.
- Work with divisional, site and functional leadership to ensure the achievement of strategic business and corporate governance requirements associated with compliance and regulatory law matters.
- 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, whether or not the candidate is currently admitted to practice in that jurisdiction.
- Certification as an ISO 13485 auditor strongly preferred.
- 15+ years of relevant healthcare regulatory law experience.
- Ability to effectively communicate with and influence a wide spectrum of individuals: from government officials, to attorneys, executives, associates and agents.
- Ideally have 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, marketing and post-market quality system requirements.
- In-depth knowledge of EU MDR and ISO 13485 and other relevant ISO standards (e.g., ISO 14971, ISO 9001).
- 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.
- Demonstrated ability to lead through influence and navigate controversial situations and negotiations.
- Deep understanding of regulatory requirements for connected device solutions, including software, digital health and infusion category products.
- 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 and succinctly.
- 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.
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