Selected Intern's Day-to-day Responsibilities Include

- Support FDA 510(k) documentation, regulatory dossier preparation, submissions, and responses.
- Research FDA regulations, guidance documents, and applicable regulatory standards.
- Assist with medical device classification, Product Code identification, and predicate-device assessments.
- Support regulatory activities and documentation for the Australian veterinary market.
- Assist with ISO internal and external audit activities.
- Support and maintain Post-Market Surveillance (PMS) activities and documentation.
- Prepare, review, and maintain regulatory, technical, and compliance documentation across different markets.
- Support technical writing and regulatory dossier preparation.
- Provide regulatory support and subject matter expertise (SME)



assistance to cross-functional teams as required.
- Coordinate with R&D;, Quality, Software, Clinical, and Testing teams on regulatory and compliance activities.

About Company: We are a startup spun out of IIT Bombay, currently based in SINE, IIT Bombay. We provide an creative medical device to doctors that facilitates early screening and better diagnosis of specific heart/lung diseases. We are trying to improve the Indian healthcare system by providing doctors with technologically advanced medical devices. We commit to the betterment of society. Our device can impact millions of lives.

📌 Regulatory Affairs Internship in Bangalore (Bengaluru)
🏢 AyuSynk.ai
📍 Bengaluru