Regulatory Affairs Executive in Bodhgaya

Technoculture Research is re-imagining how the world measures health. We build micro-scale electrochemical laboratories that place lab-grade accuracy directly in the hands of clinicians, community health workers, and patients at home. Our platform fuses microfabricated electrodes, novel surface chemistries, and microfluidics to run protein, nucleic-acid, and metabolite assays within minutes.

By replacing costly optical detection with electron sensing, we reduce instrument and per-test costs by roughly an order of magnitude, making precision diagnostics truly accessible. Our mission is to make diagnostics abundant so that every critical health decision is guided by immediate, affordable results.

We are seeking a Regulatory Affairs Executive to manage and support regulatory compliance activities for our diagnostic products and research initiatives. The candidate will ensure adherence to applicable regulatory guidelines, prepare documentation for approvals, and coordinate with internal teams to support product development in line with regulatory standards.

Key Responsibilities

• Prepare, review, and maintain regulatory documentation for product development and approvals.
• Ensure compliance with national and international regulatory requirements, including CDSCO, ICMR, and ISO standards.
• Coordinate with cross-functional teams (R&D, QA, Manufacturing) to align regulatory strategies.
• Assist in the submission of regulatory filings, licenses, and approvals.
• Monitor updates in regulatory guidelines and assess their impact on ongoing projects.
• Maintain accurate records of regulatory submissions, approvals, and correspondence.
• Support internal and external audits by preparing required documentation.
• Assist in drafting SOPs, technical files, and compliance reports.
• Communicate with regulatory authorities when required.
• Ensure all activities comply with company policies and regulatory standards.
  
  

About Company: Technoculture Research is re-imagining how the world measures health. We build micro-scale electrochemical laboratories that bring lab-grade accuracy directly into the hands of clinicians, community health workers, and even patients at home. Our platform integrates microfabricated electrodes, novel surface chemistries, and microfluidics to run protein, nucleic-acid, and metabolite assays within minutes. By replacing costly optical detection with electron sensing, we significantly reduce instrument and per-test costs, making precision diagnostics truly accessible. Our mission is to make diagnostics abundant, so every critical health decision is guided by immediate, affordable results.