Research Associate II

Responsibilities

• Develop, edit, format, and maintain R&D documentation including Design History Files (DHF), SOPs, protocols, reports, and technical files.
• Manage risk management documentation such as FMEA and ISO 14971 files.
• Ensure all documentation complies with regulatory requirements including FDA (21 CFR Part 820, Part 11), ISO 13485, ISO 14971, ICH guidelines, and EU MDR.
• Manage document version control, approvals, change requests, and archival using Electronic Document Management Systems (EDMS).
• Support internal and external audits by preparing necessary documentation.
• Collaborate with R&D scientists, engineers, quality, and manufacturing teams to translate technical content into compliant documentation.

Requirements

• 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 management systems (QMS).
• Proven experience working in compliance with FDA, ISO, and ICH guidelines.
• Proficiency with Electronic Document Management Systems (EDMS) tools.
• Excellent written and verbal communication skills with high attention to detail.

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. Built on a 70-year legacy of innovation in kidney care, Vantive is an independent company dedicated to delivering best-in-class therapies and digital solutions that transform the dialysis experience and beyond.