Regulatory Affairs Director, Software & Digital Health

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.

One of Vantive's key objectives is to be a leader in digital health supporting our vital organ therapies. Vantive had the first digitally connected peritoneal dialysis cyclers and has continued to innovate in the digital space ever since. Digital innovation is an imperative for patient care in the home setting and is essential to fulfill Vantive's mission of Extending Lives >>
Expanding possibilities.

This position serves as Vantive's regulatory subject matter expert and thought leader related to digital products and services. The position will be responsible for establishing policies and procedures governing regulatory activities for Vantive's digital portfolio. The RA Digital Health Director is accountable for maintaining the company's compliance to software and cybersecurity requirements related to our products. This position is charged with strengthening the organization's digital acumen;

and to continuously improve cross-organizational cooperation with IT, research and marketing functions. The RA Digital Health Director will also be Vantive's voice in digitally focused committees and working groups, as well as at conferences and trade shows.

The RA Digital Health Director is an individual contributor but will indirectly lead a significant number of regulatory professionals supporting digital products and programs.

• Develop regulatory strategies designed to expedite global international approvals of digital products.
• Develop regulatory policies and procedures for assessing and managing digital products, including those with artificial intelligence / machine learning.
• Act as Regulatory Subject Matter Expert on digital, cybersecurity, and artificial intelligence for Vantive.
• Represent Vantive externally on standard committees and industry working groups focused on digital, AI and cybersecurity.
• Lead community of practice for Vantive's regulatory staff who support digital products.
• Partner with cross-functional leaders supporting Vantive's digital portfolio.
• Identify new regulatory requirements and implement compliance strategies.
• Manage key regulatory consultants for digital programs.
• Develop and maintain training curriculum to upskill organization related to digital product requirements.
• Assess current projects, programs, and competencies to strengthen the organization's digital acumen; continuously improve cross-organizational cooperation with IT, research and marketing functions.
• Support regulatory strategies for new digital product development.
• Advise on changes which may require RA submissions.
• Represent Vantive and present at software, cybersecurity and digital health conferences.
• Participate in business development activities related to digital products.

• Minimum of 10 years' experience with increasing responsibilities in global regulatory affairs and compliance, of which at least five (5) years shall have been in a senior role, interacting with regulatory agencies and other policy makers.
• Software as a Medical Device (SaMD) product experience is required. Prior experience with Artificial Intelligence / Machine Learning is preferred.
• Expert understanding of Software standards…