Qualification: M.Sc / B.Sc / B.Pharm  

Experience: 0-2 Years | Freshers with strong academic background encouraged

About Blue Neem Medical Devices Pvt. Ltd.

Blue Neem is a medical device company focused on developing innovative, affordable healthcare solutions. We’re building a team of passionate professionals to support product evaluation, clinical validation, and regulatory compliance.

Role Overview

As an Evaluation Coordinator, you will be responsible for planning, executing, and documenting product evaluations and usability studies for our medical devices. You’ll work closely with R&D, Quality, Regulatory, and Clinical teams to ensure our devices meet safety, performance, and user requirements before market launch.

Key Responsibilities

1. Product Evaluation: Coordinate and conduct bench testing, usability studies, and pre-clinical evaluations of medical devices as per study protocols.

2. Documentation: Prepare and maintain Evaluation Plans, Test Protocols, Observation Records, and Final Evaluation Reports in compliance with ISO 13485 & regulatory guidelines.

3. Clinical Coordination: Liaise with hospitals, clinicians, and KOLs to schedule device demonstrations, collect feedback, and document clinical observations.

4. Data Management: Collect, compile, and analyze evaluation data using Excel/Pandas. Ensure data integrity and traceability for audits.

5. Regulatory Support: Assist QA/RA team in compiling technical documentation for CDSCO, CE, and FDA submissions related to device performance.

6. Cross-functional Collaboration: Work with R&D to communicate user feedback, with Quality for CAPA inputs, and with Marketing for claims validation.

7. Compliance: Ensure all evaluation activities follow SOPs, Good Documentation Practices, and applicable medical device regulations.

Required Qualifications & Skills

- Education: M.Sc in Life Sciences/Biotechnology/Microbiology / B.Sc / B.Pharm

- Knowledge: Basic understanding of medical devices, human anatomy, clinical workflows, and lab practices

- Technical Skills: MS Excel, MS Word, PowerPoint. Exposure to data recording & report writing

- Documentation: Strong attention to detail with ability to maintain clear, audit-ready records

- Communication: Good written and verbal English. Comfortable interacting with doctors, nurses, and lab staff

- Travel: Willingness to travel to hospitals/clinical sites for evaluations when required

Preferred Skills

1. Internship/project experience in medical devices, pharma, or clinical research

2. Familiarity with ISO 13485, IEC 62366 - Usability, or Good Clinical Practice

3. Basic data analysis using Excel or Google Sheets

4. Knowledge of sterilization, biocompatibility, or risk management is a plus

Who You Are

Detail-oriented, enthusiastic, and eager to learn. You enjoy hands-on work, can follow protocols rigorously, and communicate observations objectively. You’re passionate about improving patient care through safe and effective medical devices.

What We Offer

✅ Exposure to end-to-end medical device lifecycle from R&D to market  

✅ Training on regulatory standards and clinical evaluation processes  

✅ Collaborative work environment with doctors, engineers, and scientists  

✅ Career growth into Clinical Affairs, Regulatory Affairs, or QA roles  

✅ Competitive salary + benefits as per industry standards