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

- Solid technical and regulatory documentation skills
- Good understanding (or strong interest) in medical device regulations
- Excellent written English (this job involves a lot of writing—proper writing)
- High attention to detail and structured thinking
- Comfortable working with Word, Excel, and document templates
- Willingness to learn, accept feedback, and improve fast

What You Will Gain

- Hands-on exposure to real regulatory and QMS projects
- Practical understanding of global medical device regulations
- Opportunity to work with latest medical device technologies
- Mentorship from experienced QA/RA professionals
- Potential for conversion to a full-time QA/RA role based on performance

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