Regulatory Affairs Associate

Ayati Devices Private Limited; Bengaluru Urban; On-site; INR 600,000 - 900,000; Full time

Job summary

Ayati Devices Private Limited in Bengaluru North, India is seeking a Regulatory Affairs Associate to navigate medical device regulations and manage submissions. You will prepare and file regulatory documents, maintain licences, and support post-market activities across multiple regulations and markets.

You will handle ISO 13485 QMS activities, risk management, and documentation control, ensuring accuracy and compliance.

Qualifications

• 1–2 years of hands‑on regulatory affairs experience in the medical device industry.
• Working knowledge of Medical Devices Rules 2017, ISO 13485 and ISO 14971.
• Exposure to EU MDR, US FDA or ASEAN regulations is an advantage.
• Strong technical writing, attention to detail and organised document control.
• Good communication skills in English; proficiency in MS Office.

Responsibilities

• Prepare Device Master Files and Plant Master Files per MDR 2017; file and track CDSCO applications on the SUGAM portal.
• Respond to CDSCO queries and maintain licence validity, renewals and post-approval changes.
• Support EU MDR technical documentation, GSPR checklists and FDA 510(k) submissions.
• Maintain risk management files (ISO 14971) and collate test evidence (IEC 60601-1, IEC 60601-1-2, ISO 10993).
• Review labels, IFUs and UDI data for regulatory compliance.
• Support ISO 13485 QMS activities: document control, CAPA, change control and audits.
• Support post-market surveillance, complaint handling and Materiovigilance (MvPI) reporting.

Skills

Technical writing

Attention to detail

Document control

English communication

Tools

MS Office

Job description

Regulatory Affairs Associate

Bangalore North, India | Posted on 10/27/2026

Ayati Devices designs and manufactures screening and imaging medical devices in diabetology, neurology, cardiovascular care and podiatry.

Key Responsibilities

• Prepare Device Master Files and Plant Master Files per MDR 2017; file and track CDSCO applications on the SUGAM portal.
• Respond to CDSCO queries and maintain licence validity, renewals and post-approval changes.
• Support EU MDR technical documentation, GSPR checklists and FDA 510(k) submissions.
• Maintain risk management files (ISO 14971) and collate test evidence (IEC 60601-1, IEC 60601-1-2, ISO 10993).
• Review labels, IFUs and UDI data for regulatory compliance.
• Support ISO 13485 QMS activities: document control, CAPA, change control and audits.
• Support post-market surveillance, complaint handling and Materiovigilance (MvPI) reporting.

Requirements

• 1–2 years of hands‑on regulatory affairs experience in the medical device industry.
• Working knowledge of Medical Devices Rules 2017, ISO 13485 and ISO 14971.
• Exposure to EU MDR, US FDA or ASEAN regulations is an advantage.
• Strong technical writing, attention to detail and organised document control.
• Good communication skills in English; proficiency in MS Office.