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Regulatory & Operations Associate – AmyScan Healthcare

Published on

AmyScan Healthcare

Master’s degree in Biotechnology, Life Sciences, or Healthcare-related fields.

Mumbai

1–2 years

Verified Job

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AmyScan Healthcare Pvt. Ltd., a medtech startup incubated at IIT Bombay, is transforming diagnostics for neurodegenerative diseases with its pioneering blood-based diagnostic platform for Parkinson’s disease. The company is now hiring a Regulatory & Operations Associate in Mumbai.

This is an excellent opportunity for candidates with expertise in regulatory affairs, compliance, grant writing, and healthcare operations to contribute directly to breakthrough innovations in diagnostics.


🔑 Job Responsibilities

As a Regulatory & Operations Associate, you will:

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  • Regulatory & Compliance
    • Prepare regulatory submissions and documentation (CDSCO, ICMR, ISO standards).
    • Draft SOPs, quality manuals, and manage compliance processes.
    • Liaise with regulatory consultants to ensure diagnostic product approvals.
  • Grant Writing & Funding
    • Write and submit compelling grant proposals (DST, DBT, BIRAC, private foundations).
    • Build and maintain funding relationships with investors and agencies.
    • Prepare presentations, reports, and investor updates.
  • Operations & Partnerships
    • Coordinate with clinical partners, laboratories, and healthcare professionals.
    • Oversee biomedical laboratory operations, equipment procurement, and quality control.
    • Support day-to-day executive and startup operations.

🎓 Required Qualifications

  • Master’s degree in Biotechnology, Life Sciences, or Healthcare-related fields.
  • 1–2 years of experience in diagnostics, medical devices, or healthcare sector.
  • Proven grant writing experience with successful track record.
  • Working knowledge of CDSCO, ICMR, ISO standards.
  • Familiarity with clinical validation and regulatory submission processes.
  • Understanding of laboratory operations and quality management systems.

Preferred Experience

  • Hands-on experience with diagnostic device approvals in India.
  • Prior work in a startup or early-stage healthcare company.
  • Knowledge of neurodegenerative disease diagnostics.
  • Clinical trial coordination and partnership management.

💼 Benefits

  • Competitive salary (₹5–7 LPA, depending on experience).
  • Work in the dynamic IIT Bombay innovation ecosystem.
  • Hands-on regulatory affairs experience in a medtech startup.
  • Direct impact on breakthrough diagnostic technology.
  • Collaborative and growth-oriented work environment.

📩 Application Process

Interested candidates should send:

  • Updated Resume (education, experience, past roles).
  • Cover Letter (max 500 words) explaining your interest and alignment with the role.

👉 Email applications to info@amyscan.com with subject line:

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