Regulatory & Operations Associate

Job Title:

Regulatory & Operations Associate – Diagnostics

Company:

AmyScan Healthcare Pvt. Ltd.

Location:

SINE, IIT Bombay

Employment Type:

Full-time

About AmyScan Healthcare:

AmyScan Healthcare Pvt. Ltd. is a healthcare/medtech startup developing research-backed diagnostic innovations for neurodegenerative diseases, beginning with a blood-based diagnostic platform for Parkinson's disease. The technology is developed by
the SCAN Centre and the Department of Bioscience and Bioengineering,
IIT Bombay. Our mission is to bridge cutting-edge science with accessible healthcare solutions to improve patient outcomes.

Role Overview:

We are seeking a motivated regulatory affairs and operations professional, preferably with experience in the diagnostics/healthcare industry. This role combines regulatory compliance, grant writing, funding relationship management, and operational responsibilities, offering the opportunity to work closely with our founding team in a fast-paced startup environment within the IIT Bombay ecosystem.

Key Responsibilities:

1) Regulatory & Compliance:

• Lead regulatory documentation, approvals, and compliance processes (CDSCO, ICMR, ISO standards)
• Draft SOPs, quality documents, and regulatory submissions for diagnostic products
• Coordinate with regulatory consultants and ensure compliance with healthcare regulations

2) Grant Writing & Funding:

• Research and write compelling grant proposals for government agencies (DST, DBT, BIRAC) and private foundations
• Prepare compelling presentations for grant applications
• Manage relationships with existing funding partners and investors
• Identify new funding opportunities and coordinate application processes
• Prepare investor communications and funding reports

3) Operations & Partnerships:

• Coordinate with external stakeholders including clinical partners, laboratories, and healthcare professionals
• Oversee biomedical laboratory requirements, equipment procurement, and quality control processes
• Support day-to-day executive and operational tasks to ensure smooth company functioning
• Contribute to cross-functional projects in our dynamic startup environment

Required Qualifications

:

• Master's degree or above in Biotechnology, Life Sciences, Healthcare, or any related fields
• 1-2 years of experience in diagnostics, medical devices, or the healthcare industry, with a preference for regulatory process.
• Demonstrated grant writing experience with a successful funding track record
• Working knowledge of CDSCO, ICMR, and ISO standards for diagnostic devices
• Understanding of clinical validation processes and regulatory submission requirements
• Familiarity with biomedical laboratory operations and quality management systems
• Experience with healthcare professional communication and clinical partnerships

Preferred Experiences:

• Experience with diagnostic device regulatory approvals in India
• Track record of successful grant applications (please specify amounts secured)
• Previous startup or early-stage company experience
• Knowledge of neurodegenerative disease diagnostics or biomarker development
• Familiarity with clinical trial coordination and healthcare partnerships

What We Offer:

• Competitive salary commensurate with experience and qualifications
• Opportunity to work at the intersection of cutting-edge science, innovation, and healthcare
• Hands-on exposure to complete the regulatory affairs lifecycle in a growing startup
• Collaborative environment with significant growth opportunities
• Work within the dynamic IIT Bombay innovation ecosystem
• Direct impact on breakthrough diagnostic technology for neurodegenerative diseases

Application Instructions:

Please send the following to

with the subject line:
YOUR NAME (Application – Regulatory & Operations Associate
).

1. Detailed Resume

highlighting your educational background, total years of relevant experience, and descriptions of your past professional roles
2. Cover Letter

(maximum 500 words) explaining how your interests, skills, and motivations align specifically with this opportunity at AmyScan Healthcare