Vantive · 1 month ago
Regulatory Affairs Director, Software & Digital Health
United States
Full-time
Remote
Director/Executive
$192K/yr - $256K/yr
10+ years expVantive is a vital organ therapy company focused on extending lives and improving patient care through digital solutions. The Regulatory Affairs Director will serve as the regulatory subject matter expert for digital products, responsible for establishing policies, ensuring compliance, and leading regulatory strategies to expedite global approvals.
Health CareMedicalTherapeuticsWellness
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
Qualification
Required
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
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
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
Bachelor's Degree in technical or technology related field required
Minimum of 10 year experience in RA or a related discipline
Preferred
Prior experience with Artificial Intelligence / Machine Learning is preferred
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
International experience / exposure preferred
Benefits
Medical, dental and vision coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Aon Pooled Employer Plan (“Aon PEP”)
Vantive’s 401(k) retirement savings plan
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
The Employee Discount Program
The Employee Assistance Program (EAP)
Childcare benefits
Company
Vantive
Vantive US Healthcare LLC specializes in kidney care and organ support therapies with digital solutions.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-08-13Acquired
Recent News
Spectral Medical Inc.
2025-11-08
2025-11-01
Company data provided by crunchbase