Quality Assurance & Regulatory Affairs

Quality Assurance & Regulatory Affairs Executive

Role Overview

The Quality Analysis & Regulatory Affairs professional will be responsible for establishing, maintaining, and improving quality systems while managing regulatory submissions and compliance for IVD products. This role requires a hands-on approach, cross-functional collaboration, and the ability to work in a dynamic startup environment.

Key Responsibilities

Quality Analysis / Quality Assurance

• Establish, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements.
• Prepare, review, and control quality documentation including SOPs, work instructions, records, and forms.
• Conduct internal audits, gap assessments, and support external audits (certification bodies, regulators, customers).
• Manage CAPA, deviations, change controls, and non-conformances.
• Support risk management activities (ISO 14971) including risk analysis and mitigation.
• Oversee incoming, in-process, and final quality checks for IVD products.
• Ensure product traceability, batch release documentation, and quality records maintenance.

Regulatory Affairs

• Manage regulatory submissions and approvals for IVD products (India CDSCO and/or international markets).
• Prepare and maintain technical documentation / dossiers, including device master files, labeling, IFUs, and validation reports.
• Ensure compliance with applicable regulations such as IVDR / ICMR / CDSCO / CE / FDA (as applicable).
• Act as the primary point of contact for regulatory authorities and notified bodies.
• Monitor regulatory updates and assess impact on existing and upcoming products.
• Support product registration, renewals, variations, and post-market compliance activities.

Cross-Functional Collaboration

• Work closely with R&D, Manufacturing, Supply Chain, and Operations teams to ensure quality and regulatory requirements are met throughout the product lifecycle.
• Provide regulatory and quality guidance during product development, scale-up, and commercialization.

Qualifications & Experience

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field.
• 2–6 years of experience in Quality Assurance and/or Regulatory Affairs within IVD or medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, and IVD regulatory frameworks.
• Experience with CDSCO / CE / FDA submissions is a strong advantage.
• Familiarity with validation, documentation control, and audit processes.

Job Type: Full-time

Pay: ₹30,000.00 - ₹45,000.00 per month

Work Location: In person