Regulatory Affairs Associate
Ayati Devices Private Limited · Healthcare & Pharma
- Bangalore North, India
- On-site
- Posted today
- Healthcare & Life Sciences
- Full time
About the job
Role Summary
Ayati Devices designs and manufactures screening and imaging medical devices in diabetology, neurology,
cardiovascular care and podiatry. The Regulatory Affairs Associate will prepare and maintain regulatory documentation
and submissions for India (CDSCO) and international markets.
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.
How to Apply
Send your CV with the subject line “Regulatory Affairs Associate”, stating current CTC, expected CTC and notice period.