Quality & Regulatory Executive

Neuranics Lab; Gurugram District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Neuranics Lab in Gurugram, India, seeks a Quality and Regulatory Executive to drive compliance with ISO 13485, IEC 60601, and global medical device regulations. The role collaborates across design, manufacturing, and R&D to ensure product conformity and successful regulatory filings.

The ideal candidate has 2+ years in quality assurance/regulatory roles for medical devices or wearables, with strong documentation and audit experience. Immediate joiners preferred.

Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, Electronics, or related field.
• 2+ years in quality assurance and regulatory compliance (medical devices, electronics, or wearables).
• Knowledge of ISO 13485, IEC 60601, GMP, FDA 21 CFR Part 820, MDR/IVDR/EU.

Responsibilities

• Develop and implement QMS in line with ISO 13485 and IEC 60601.
• Ensure compliance with Indian and global medical device regs (CDSCO, CE, FDA).
• Coordinate with design, manufacturing, and R&D to maintain product compliance.
• Prepare regulatory submissions, technical files, and risk management docs.
• Conduct internal and supplier audits; implement CAPA.
• Interface with regulatory bodies, cert bodies, and testing labs.
• Maintain documentation and records for compliance.
• Educate teams on quality and regulatory best practices.

Skills

Regulatory compliance

Quality systems (QMS)

Medical devices regulations

Risk management (ISO14971)

Audits & documentation

Effective communication

Education

Bachelor's or Master's in Biomedical Eng/Tech

Job description

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.