About Us

Neuranics Lab is an creative startup at the forefront of developing cutting-edge device technologies. As we scale our operations, we're seeking a Quality and Regulatory Executive to ensure compliance with industry standards and drive quality assurance in our manufacturing processes.

Key Responsibilities:
Develop and implement QMS in compliance with ISO 13485, IEC 60601 and other relevant standards.
Ensure compliance with Indian and global medical device regulations (CDSCO, CE, FDA, etc.).
Work closely with teams across design, manufacturing, and R&D; to ensure product compliance.
Prepare regulatory submissions, technical files, and risk management documentation.
Conduct internal audits, supplier audits, and implement CAPA (Corrective and Preventive Actions).
Interface with regulatory agencies, certification bodies, and testing labs.
Ensure proper documentation and record-keeping for compliance.




Educate and train internal teams on quality and regulatory best practices.

Qualification & Skills:
Bachelors or Masters degree in Biomedical Engineering, Biotechnology, Electronics, or related field.
2+ years of experience in quality assurance and regulatory compliance (medical devices, electronics, or wearable tech preferred).
Familiarity with ISO 13485, IEC 60601, GMP, FDA 21 CFR Part 820, MDR/IVDR/EU).
Exposure to CDSCO MD-5 and MD-13 will be an added advantage.
Experience in regulatory filings, audits, and compliance documentation.
Knowledge of risk management (ISO 14971).
Robust attention to detail, analytical, and problem-solving skills.
Excellent communication skills for dealing with regulatory bodies and internal teams.
Immediate Joiners or candidates with a maximum notice period of 15 days are preferred.

📌 Quality & Regulatory Executive Gurugram
🏢 Neuranics Lab
📍 Gurugram