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.

Essential Duties and Responsibilities:

• 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

Qualifications:

• 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 (e.g. IEC 80001; IEC 82304; IEC 63304; IEC 81001, IEC 62443, etc.)

• Established track record of successful regulatory submissions and approvals.

• Strong competency in Quality Management System requirements and Risk Management principles

• Solid basis in scientific approach and an ability to deal with in depth technical to foster a high degree of scientific credibility, both within the technical community inside the organization and with regulatory agencies.

• Strong strategist and operational leader; capable of getting the job done and dealing effectively with health authorities.

• International experience, including successful submission of product license applications and other dossiers with subsequent approval by regulatory authorities in relevant countries.

• Strategic thinker capable of executing on strategy across entire digital portfolio; demonstrated success in setting regulatory strategy and in obtaining worldwide product approvals, particularly those involving complex issues; ability to provide guidance to senior management on digital product development strategies through all stages of the product development cycle

Requirements:

• Experience affecting direction and decision-making within development programs and regulatory agencies; successful track record of taking products through development and approval.

• Strong knowledge and experience with global regulatory affairs and regulations; demonstrated ability to develop and maintain excellent working relationships with U.S. and international health authorities and significant experience presenting to global regulatory authorities.

• Flexible, positive and creative thinker with the proven ability to develop and implement innovative programs and processes; competence in analysis and solving of problems and the ability to prioritize and make tradeoffs to achieve goals.

• Personal leadership qualities and interpersonal / communication skills which will instill confidence at large and amongst regulatory health authorities and other outside organizations.

• Team player, who understands that success is only possible in conjunction with departmental and cross functional peers.

Education and/or Experience:

• Bachelor's Degree in technical or technology related field required.

• Advanced degree in life sciences, engineering, or software related field is preferred but not required if candidates possess requisite experience in global regulatory affairs and quality.

• Minimum of 10 year experience in RA or a related discipline.

• International experience / exposure preferred

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $192,000 - $256,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

We are open to hiring candidates remotely throughout the US.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Vantive's US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

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