Apply on Kit Job: kitjob.in/job/46ox0z

About

We are building the next-generation AI-driven Regulatory & Compliance Intelligence platform for MedTech manufacturers. Our mission is to simplify regulatory complexity by combining domain expertise with cutting-edge AI, semantic search, and clause-aware automation tools. You will work at the intersection of regulatory affairs, quality systems, and AI innovation, contributing directly to the development of our core product.

Role Overview

We are looking for a QA/RA Executive who can collaborate closely with the tech and product teams to ensure regulatory accuracy, domain alignment, and quality compliance across the platform. You will validate regulatory logic, help shape requirement mappings, analyze industry documentation, and support the creation of compliant frameworks aligned with ISO 13485, FDA QSR 21 CFR 820, EU MDR, and related standards.

This role is perfect for someone who loves regulatory work and wants to contribute to an AI-powered product.

Key Responsibilities

Regulatory & Quality Expertise

- Review and interpret standards such as ISO 13485:2016, ISO 14971, FDA QSR 21 CFR 820, and EU MDR/IVDR.
- Identify clause-by-clause requirements and map them to expected documents, processes, and evidence.
- Validate compliance checklists, rules, and automated logic created by the tech team.

Collaboration with Tech Team

- Translate regulatory requirements into structured datasets, workflows, and rule sets.
- Work with developers on compliance modules, RAG workflows, and traceability logic.
- Participate in building the regulatory knowledge graph & clause mapping system.

Document & Evidence Review

- Review DMRs, DHRs, SOPs, WIs, forms, and real-world QMS documents to ensure proper interpretation.
- Annotate documents for training data, classification, semantic chunking, and clause mapping.




- Support POC testing and validate outputs of the AI compliance engine.

Quality System Support

- Assist in building internal QMS for product development.
- Maintain document control, versioning, and compliance records.
- Prepare checklists, templates, guidance documents, and SOPs relevant to MedTech manufacturers.

Cross-Functional Input

- Provide QA/RA input into product design, workflows, UI/UX, and customer onboarding.
- Coordinate with regulatory advisors and domain experts.
- Stay updated with regulatory changes that may impact the product.

Requirements

Must-Have

- 6–7+ years experience in QA/RA for medical devices or healthcare technology.
- Strong familiarity with ISO 13485, ISO 14971, and basic FDA QSR principles.
- Experience working with QMS documentation (SOPs, WIs, DMR, DHR, CAPA, NCRs, etc.).
- Ability to analyze regulatory clauses and translate them into structured information.
- Excellent written communication and precision in documentation.

Nice-to-Have

- Experience with AI tools, RAG systems, or data annotation (not required but a big plus).
- Experience with EU MDR/IVDR, 21 CFR 820 revisions, UDI, labeling, or sterilization records.
- Exposure to tech environments or SaaS products.
- Ability to work independently in a rapid-paced startup environment.

Soft Skills

- Highly detail-oriented
- Strong analytical thinking
- Collaborative mindset
- Comfortable working cross-functionally
- Passion for innovation in regulatory compliance

What We Offer

- Opportunity to work at the cutting edge of MedTech
- Direct collaboration with founders & domain experts
- Growth path into senior QA/RA leadership
- Remote-first culture
- Competitive compensation (aligned with experience)

How to Apply

Send your resume and a short note explaining your experience with Regulations and Medical Device QMS to:

Apply on Kit Job: kitjob.in/job/46ox0z

📌 QA/RA Executive – MedTech Device Compliance (Kota)
🏢 eForte
📍 Kota