Corporate Counsel, Clinical & Regulatory

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

POSITION OVERVIEW:  

This position is part of the Regulatory legal team, within the Legal Department, and will support both our Chronic and Acute business units globally.  The position involves handling projects, transactions or matters under the supervision of Associate General Counsel, Regulatory. The position will serve relevant business leadership and other law department members as a legal advisor in defined areas of clinical operations, medical operations, state licensing matters, as well as medical device and pharmaceutical regulatory law. Accordingly, candidates should have depth of knowledge in Regulatory Law, including clinical trials and related contracting issues.

The candidate selected for this role will:

• Provide direct support to Vantive’s worldwide medical organization—particularly Clinical Operations and Medical Operations—on a wide variety of legal issues including clinical trials, contracts, technology transfers, regulatory considerations, general operating issues and international complexities.
• Provide Regulatory Law guidance and counseling to other business and functional teams, including quality and regulatory affairs, ethics & compliance, R&D, patient access, sales and marketing, finance, and others. This position entails advising on legal-regulatory risks for complex/non-standard US/regional/global issues—including the development of action plans. 
• Collaborate with legal colleagues and cross-functional teams to ensure appropriate expertise is applied to legal-regulatory issues, including regulatory strategy, product development & product approvals; advertising & promotion; post-approval compliance; regulatory enforcement actions; due diligence reviews & transactional support.
• Support state licensing initiatives and projects.
• Train business on Regulatory Law topics, including: Good Clinical Practice and clinical trials, good promotional practices, and other relevant regulatory issues.

EDUCATION AND EXPERIENCE:

• JD or international equivalent from a nationally or internationally recognized institution; licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States.  
• Minimum of 5-7 years of relevant professional experience with a mix of work in a high-caliber law firm, government agency, and/or comparable corporate environment.  
• Experience in the pharmaceutical or device industry, and/or similar healthcare regulatory experience. 
• Working knowledge in one or more of the following areas: Regulatory requirements from HHS, FDA, CMS, and various state regulators, and industry codes governing interactions with healthcare professionals.

ESSENTIAL SKILLS:

• Strong business and personal ethics and integrity
• Demo