Location: Remote / Hybrid (Bangalore)
Duration: 6–12 months (Convertible to Full time based on performance)

About MedQCompliance

MedQCompliance is a specialized Quality & Regulatory consulting firm supporting medical device, IVD, SaMD, and AI/ML-based digital health companies across global markets including the US, EU, UK, and APAC. We work hands-on with startups and established manufacturers to build compliant, audit-ready systems and support in global regulatory clearances.

Role Overview
We are looking for a QA/RA Project Intern to support ongoing client projects involving Quality Management Systems (QMS), regulatory, and technical documentation for medical devices, IVDs and software-based medical technologies.

Key Responsibilities

Quality Management System (QMS) Support
Assist in creation, review, and maintenance of QMS documents including:
SOPs, Work Instructions, Policies, Templates, and Forms
Support QMS alignment with:
ISO 13485
QMSR
EU MDR / IVDR requirements

Regulatory & Technical Documentation
Support preparation and review of:




Technical Documentation / Design Dossiers
Risk Management Files (ISO 14971)
Clinical Evaluation documentation (supporting role)
SDLC documentation
Assist in regulatory submissions and assessments for:
US FDA (510(k), De Novo
EU CE marking (MDR/IVDR)
Other international regulatory pathways (as needed)

Project & Client Support
Work closely with QA/RA team on live client projects
Track action items, document gaps, and review comments
Participate in internal project discussions and learning sessions

Eligibility & Qualifications
Education
Graduate degree in Life Sciences/ Biotechnology/ Biomedical Engineering or a closely related discipline

Experience (Preferred)
0.5 – 2 years of experience in:
Medical devices, IVDs, or digital health companies
Quality, Regulatory, or documentation roles
Internship or project exposure in medtech is a strong plus

Required Skills & Competencies
Robust technical and regulatory documentation skills

📌 QA/RA Project Intern (Bengaluru)
🏢 MedQCompliance
📍 Bengaluru