QA/RA Lead

Company Description

Adiuvo Diagnostics Pvt. Ltd. is a techno-social enterprise focused on developing cutting-edge platform technologies in optoelectronics to support early disease detection. The company is dedicated to enhancing healthcare diagnostics, particularly in underserved communities. Through innovative solutions, Adiuvo aims to make advanced diagnostic tools accessible to low-resource settings, contributing to improved global healthcare outcomes.

7–12 years in QA/RA roles within the medical device industry

(MUST have ISO 13485 , FDA & EU MDR experience)

Senior QA/RA & QMS Manager

• Quality Assurance
• Regulatory Affairs
• ISO 13485 Quality Management System
• Production documentation (DHR, DMR, NC, CAPA)
• Technical File & MDR preparation
• Compliance with FDA QSR (if applicable)
• Managing external partner expectations and defending documentation

critical single-person leadership role

1. Quality Assurance (QA)

• Maintain product quality throughout development and manufacturing.
• Review and approve SOPs, work instructions, and quality records.
• Lead NC investigations, RCA, and CAPA implementation.
• Supervise calibration and functional test documentation.
• Conduct internal audits and readiness checks.
• Ensure all DHRs and batch records are complete and audit-ready.

2. Quality Management System (QMS) – ISO 13485 Owner

• Own and maintain the full ISO 13485 QMS.
• Implement and update procedures based on regulatory changes.
• Conduct periodic management reviews.
• Train production, QC, and engineering teams on QMS processes.
• Manage document control, change control, DHF, DMR.
• Ensure supplier qualification and traceability.

3. Regulatory Affairs (RA)

• Prepare technical documentation for

  EU MDR (Annex II & III)

  .
• Coordinate risk management files (ISO 14971).
• Prepare and maintain clinical evaluation and PMS documentation.
• Support regulatory submissions (CE, FDA if required).
• Ensure labeling, IFU, and product claims comply with MDR.
• Coordinate vigilance & complaint handling procedure.

4. Documentation Control (HIGH PRIORITY)

This is critical for dealing with Kent.

• Review all DHRs before sending to partner.
• Ensure documentation is

  defensible

  and

  traceable

  .
• Clarify which documents are permissible to share vs confidential manufacturing know-how.
• Standardize documentation format to prevent partner misinterpretation.
• Act as the

  single point of contact

  for all production records.

• Bachelor’s or Master’s in Biomedical Engineering, Electrical, Mechanical, Biotechnology, or Regulatory Affairs.
• Minimum 7 years in medical device QA/RA.
• Strong experience with:
• ISO 13485
• ISO 14971
• EU MDR
• DHR, DHF, DMR management
• CAPA, NC investigations
• IQ/OQ/PQ validation
• Excellent written and verbal communication.
• Ability to stand firm during external pressure or audit scrutiny.
• Hands-on approach with the ability to work in a small-team environment.