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).
- Strong 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