R&D IT Solutions Lead, Regulatory & Compliance Systems

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.

Job Summary:

Vantive is seeking a Technical & Functional professional with expertise in Regulatory & Compliance Systems and other R&D application implementations to support digital transformation initiatives. The ideal candidate will be the single point of contact (SPOC) of designated information technology systems, including but not limited to hardware, software, databases, & applications.

This role requires a strong blend of technical expertise, hands-on implementation experience, and business process understanding to configure, integrate, and optimize these systems within a regulated environment.

Key Responsibilities:

System Implementation:

· Lead end-to-end implementation of cloning Compliance Builder, Regulatory Asset Manager and other apps in R&D by collaborating with SI partners and vendors

· Develop and support Integrations/APIs, middleware solutions, and automation workflows.

· Perform system configuration, customization, and validations.

· Develop and implement standard operating procedures (SOPs), templates, and user access controls for compliance and efficiency.

· Conduct user training sessions, workshops, and documentation development to drive system adoption.

System & Incident Management:

· Monitor system performance metrics, identify areas of improvement, & implement optimization strategies to enhance efficiency and reliability.

· Identify and mitigate risks associated with system operations, data integrity, and/or cyber security threats.

· Alert and escalate technical issues, concerns to functional leads, architects, and/or program leads.

· Communicate with incident commanders and service desk in accordance with SLA’s.

· Implement disaster recovery plans, backups, and system monitoring.

Continuous Improvement:

· Collaborate with BRM/MRM, EA, business owners, other IT functions, and/or with 3rd party system owners on system enhancements and capabilities to translate business requirements into technical designs that are globally scalable aligning with organization road maps, goals, and initiatives.

· Implement system upgrades and enhancements to improve systems’ performance, functionality, and/or security.

· Ensure the system is secure and up to date (patching, version, certificates etc.,) and the system is compliant with authentication policies.

Compliance & Validation Support

· Ensure applications deployments meet GxP and FDA 21 CFR Part 11 standards.

· Assist in computer system validation (CSV) activities, including IQ/OQ/PQ documentation and audit readiness.

· Develop and maintain system risk assessments, validation scripts, and traceability matrices.

Qualifications & Experience:

Required:

· Bachelor’s degree in computer science, Computer Engineering, or other related fields.

· 8 + years of experience in Information Systems, experience in multiple areas of IT.

· Experience with Compliance Builder, Regulatory Asset Manager, or similar compliance-focused applications.

· Strong knowledge of infrastructure management on cloud service providers (CSP - AWS Preferred), cloud computing, and IT operations.

· Experience with programming languages (e.g., C#, .NET, Java, Python), web technologies (e.g., ASP.NET Core, Angular, REST API’s), and database technologies.

· Familiarity with software development tools and methodologies, including version controls systems, and testing frameworks.

· Experience with administration and maintenance of CI/CD and DevOps tools, including managing user accounts, performing system upgrades, handling license and certificate renewals, and ensuring high availability and security compliance across environments.

· Understanding of regulatory and compliance processes in industries such as medical devices, life sciences, healthcare, or manufacturing.

Additional Skills:

· Basic project management experience (Agile, Waterfall, or hybrid methodologies).

· Strong problem-solving and analytical skills to address complex system issues.

· Excellent communication and stakeholder management skills.

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

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