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&aposs 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&aposs 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[Confidential Information]with the subject line: YOUR NAME (Application – Regulatory & Operations Associate).
- Detailed Resume highlighting your educational background, total years of relevant experience, and descriptions of your past professional roles
- Cover Letter (maximum 500 words) explaining how your interests, skills, and motivations align specifically with this opportunity at AmyScan Healthcare
