Regulatory Affairs Internship

Selected intern's day-to-day responsibilities include: 1. Support FDA 510(k) documentation, regulatory dossier preparation, submissions, and responses.

2. Research FDA regulations, guidance documents, and applicable regulatory standards. 3. Assist with medical device classification, Product Code identification, and predicate-device assessments.

4. Support regulatory activities and documentation for the Australian veterinary market. 5. Assist with ISO internal and external audit activities. 6.

Support and maintain Post-Market Surveillance (PMS) activities and documentation. 7. Prepare, review, and maintain regulatory, technical, and compliance documentation across different markets.

8. Support technical writing and regulatory dossier preparation. 9. Provide regulatory support and subject matter expertise (SME) assistance to cross-functional teams as required.

10. Coordinate with R&D, Quality, Software, Clinical, and Testing teams on regulatory and compliance activities. Who can apply: Only those candidates can apply who: • are available for full time (in-office) internship • can start the internship between 3rd Sep'26 and 8th Oct'26 • are available for duration of 6 months • have relevant skills and interests Stipend: INR₹ 7,000 - 15,000 /month Deadline: 2026-10-03 23:59:59 Other perks: Certificate, Letter of recommendation, Informal dress code, 5 days a week, Free snacks & beverages Skills required: Attention to Detail, Analytical Thinking, Effective Communication and Regulatory Affairs Other Requirements: • Requirements: • 1.

Master's degree in Regulatory Affairs (MRA) or a related field. • 2. Basic understanding of medical device regulations and international regulatory requirements.

• 3. Familiarity with key medical device standards, including: • 1. ISO 13485 – Quality Management Systems. • 2. ISO 14971 – Risk Management. • 3. IEC 60601-1 – Basic Safety and Essential Performance.

• 4. IEC 60601-1-2 – Electromagnetic Compatibility (EMC). • 5. IEC 62304 – Medical Device Software Lifecycle Processes. • 4. Understanding of FDA 510(k) regulatory requirements.

• 5. Strong technical writing, documentation, communication, and analytical skills. • 6. Excellent attention to detail and willingness to learn. • 7. Freshers and students seeking internships in Regulatory Affairs are encouraged to apply.

About Company: We are a startup spun out of IIT Bombay, currently based in SINE, IIT Bombay. We provide an innovative 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.