Regulatory Affairs Intern
Bengaluru, Karnataka, India · Full Time internship
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- Stipend
- Stipend: INR 7,000 – INR 15,000 / month
- Duration
- 6 months
- Start
- Immediately
- Openings
- 1
Applicants must be available for full-time, in-office internship, able to start between September 3 and October 8, 2026, and commit to a six-month duration. Candidates should have relevant skills and interests in regulatory affairs.
- Work mode
- In office
- Education
- Master's degree in Regulatory Affairs or related field
- Resume
- Required to apply
About the internship
About the Internship
This internship opportunity at Ayu Devices in Bangalore offers hands-on experience in regulatory affairs focused on medical devices. The selected intern will contribute to the preparation and management of regulatory submissions, primarily supporting FDA 510(k) documentation, as well as activities related to Australian veterinary market regulations and ISO audits.
Key Responsibilities
- Assist with compiling and submitting regulatory dossiers, including FDA 510(k) documentation and managing submission responses.
- Conduct research on FDA regulations, guidance materials, and applicable standards relevant to medical devices.
- Support device classification efforts such as Product Code identification and evaluating predicate-device comparisons.
- Aid regulatory documentation and compliance tasks targeting the Australian veterinary sector.
- Participate in ISO internal and external audit operations to ensure quality standards are met.
- Help maintain Post-Market Surveillance (PMS) documentation and activities post device deployment.
- Prepare, review, and update regulatory, technical, and compliance documents for multiple international markets.
- Support technical writing tasks related to regulatory dossier development.
- Provide regulatory insight and guidance as a subject matter expert to cross-department teams including R&D, Quality, Software, Clinical, and Testing divisions.
- Coordinate regulatory compliance efforts amongst various units within the organization.
Eligibility and Requirements
- Candidates must be available for a full-time, in-office internship in Bangalore.
- Must be able to begin between September 3, 2026, and October 8, 2026.
- Commitment of 6 months duration is required.
- Applicants should possess a Master's degree in Regulatory Affairs or a related discipline.
- Fundamental knowledge of medical device regulations and international regulatory requirements is essential.
- Familiarity with key medical device standards including ISO 13485 (Quality Management), ISO 14971 (Risk Management), IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), and IEC 62304 (Software Lifecycle) is expected.
- Understanding of FDA 510(k) regulatory processes is required.
- Strong technical writing capabilities along with excellent documentation, communication, analytical skills, and meticulous attention to detail are necessary.
- Fresh graduates and students looking for internship exposure in Regulatory Affairs are encouraged to apply.
Stipend and Additional Benefits
The monthly stipend ranges from INR 7,000 to INR 15,000. Other perks include a certificate upon completion, a letter of recommendation, informal dress code, a five-day workweek, and complimentary snacks and beverages.
About Ayu Devices
Ayu Devices is a startup emerging from IIT Bombay, housed in the SINE incubator at IIT Bombay. The company develops innovative medical devices aimed at early detection and improved diagnosis of certain heart and lung diseases. Their mission is to enhance healthcare in India by equipping doctors with advanced technological tools that impact the health outcomes of millions.