Quality & Regulatory Executive

About Us:
Neuranics Lab is an innovative 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.