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: A New Company Built on Our Legacy

Vantive is a newly formed, independent company built on a proud legacy of nearly 70 years in kidney care, acute therapies, and home and in‑center dialysis. As we take this next bold step forward, our mission is clear: to deliver best‑in‑class therapies that meaningfully improve the lives of patients worldwide. We offer more than a role—we offer the opportunity to shape the future of kidney care while working alongside passionate global teams who are driven by purpose, innovation, and integrity. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

• Job Title –Research Associate II

• Location – Whitefield, Bangalore

Job Summary

The Documentation Specialist supports Pharmaceutical and Medical Device R&D teams by creating, maintaining, and controlling high‑quality technical and regulatory documentation. This role ensures that all documents comply with applicable regulatory requirements, quality management systems (QMS), and internal standards throughout the product development lifecycle.

Key Responsibilities

Documentation & Authoring

• Develop, edit, format, and maintain R&D documentation including but not limited to:

• • Design History Files (DHF)

  • Standard Operating Procedures (SOPs)

  • Protocols, Reports, and Technical Files

  • Risk Management Documents (FMEA, ISO 14971 files)

  • Design Control documentation

• Ensure documents are accurate, consistent, clear, and compliant with regulatory and quality standards.

Regulatory & Quality Compliance

• Ensure documentation aligns with applicable regulations and standards, including:

  • FDA (21 CFR Part 820, Part 11)

  • ISO 13485, ISO 14971

  • ICH Guidelines

  • EU MDR

• Support internal and external audits by preparing documentation

Document Control & Lifecycle Management

• Manage document version control, approvals, change requests, and archival using electronic document management systems (EDMS).

• Ensure timely updates to documents based on design changes, CAPAs, and regulatory updates as applicable.

• Track document metrics, review cycles, and training assignments.

Cross‑functional Collaboration

• Work closely with R&D scientists, engineers, quality, and manufacturing teams.

• Translate technical and scientific content into clear, compliant documentation.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field.

• 3–7 years of experience in documentation within Pharmaceutical or Medical Device R&D.

• Strong understanding of regulated documentation practices and quality systems.

• Experience working in compliance with FDA, ISO, and ICH guidelines.

• Proficiency with EDMS tools

• Excellent written and verbal communication skills.

Key Skills & Competencies

• Technical & Regulatory Writing

• Attention to Detail

• Quality & Compliance Mindset

• Document Lifecycle Management

• Stakeholder Collaboration

• Time Management & Organization

• Analytical Thinking

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

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.