Company Description

ONCOassist® by Portable Medical Technology Ltd. is a mobile-first, CE-approved decision support app designed for oncology professionals, providing up-to-date tools and clinical content at the point of care. The platform focuses on saving time and improving the quality of patient care for busy, high-pressure oncology environments. ONCOassist® is used by healthcare professionals in more than 180 countries, reflecting its global reach and trusted utility.

The company also partners with many of the world’s leading pharmaceutical organizations, reinforcing its strong position within the oncology and medical technology ecosystem.

Role Description This full-time, remote Document Controller – QA/RA role is based in Kochi and focuses on managing documentation within a regulated medical device software environment (ISO 13485 / EU MDR).

The Document

Controller will maintain and organise quality and regulatory documentation, ensure correct version control, and support the creation, review, and approval of procedures, work instructions, and technical records. The role involves coordinating project documentation, maintaining records related to audits, CAPAs, risk management, and regulatory submissions, and ensuring that documentation aligns with internal policies and applicable standards. Day-to-day responsibilities include collaborating with QA/RA, product, and engineering teams to track document changes, support compliance activities, prepare documentation for inspections,



and communicate documentation requirements and timelines to relevant stakeholders.

Qualifications

- Strong document-related skills, including Document Management, Documentation, and Project Documentation in a regulated environment.
- Experience with Records Management practices to maintain accurate, traceable, and audit-ready quality and regulatory files.
- Effective Communication skills to collaborate with cross-functional teams and clearly convey documentation and compliance requirements.
- Familiarity with ISO 13485 and EU MDR requirements, particularly as they apply to medical device software and quality systems.
- Experience working with electronic document control systems or QMS tools, and proficiency with standard office software.
- Attention to detail, organizational skills, and the ability to manage multiple documentation tasks and deadlines.
- Relevant degree or diploma in a scientific, engineering, quality, or regulatory discipline, or equivalent practical experience.
- Prior experience in QA/RA, medical devices, or health software is an advantage.

What we are offering

- Competitive salary with annual salary reviews.
- Full time positions
- Work with a dedicated team to make a real difference to patient lives
- Training and development including support for conferences and events, certification etc
- The excitement of playing your part in building an industry-leading mobile health company.
- Apple products.
- Casual Attire.
- Flexible working options.

📌 Document Controller – QA/RA (Medical Device Software, ISO 13485 / EU MDR) (India)
🏢 Portable Medical Technology Ltd. (ONCOassist®)
📍 India