Ayati Devices Regulatory Affairs Associate Job – Bengaluru, Karnataka

Published on: November 9, 2026

Ayati Devices Private Limited has an opening for a Regulatory Affairs Associate at its Bengaluru North location, Karnataka. The company is seeking candidates with 1–2 years of hands-on experience in regulatory affairs within the medical device industry.

This role focuses on regulatory submissions, technical documentation and product compliance for Indian and international markets. Key areas of work include CDSCO applications, EU MDR documentation, US FDA 510(k) submissions, risk management and medical device quality management systems.

Candidates interested in medical device regulatory affairs can also explore Latest Regulatory Affairs Jobs and practice with our Free Regulatory Affairs Mock Test.

1. Ayati Devices Regulatory Affairs Associate Job – Overview

Company Careers Page: Visit Ayati Devices Careers to explore other opportunities.

2. About Ayati Devices Private Limited

Ayati Devices works in the medical technology sector, designing and manufacturing screening and imaging devices for healthcare applications.

Its areas of focus include:

• Diabetology
• Neurology
• Cardiovascular care
• Podiatry

The Regulatory Affairs Associate will support regulatory compliance and documentation for medical devices intended for the Indian and international markets.

3. Key Responsibilities of a Regulatory Affairs Associate

The position involves regulatory submissions, technical documentation, product compliance and quality management activities.

A. CDSCO Submissions and Licensing

• Prepare Device Master Files (DMF) and Plant Master Files (PMF) in accordance with the Medical Devices Rules, 2017.
• File and track regulatory applications through the CDSCO SUGAM portal.
• Respond to regulatory queries from CDSCO.
• Support license renewals, validity-related activities and post-approval changes.

Reference: Candidates can refer to the CDSCO Medical Devices Rules, 2017 to understand India’s medical device regulatory framework.

B. International Regulatory Documentation

• Support technical documentation under the European Union Medical Device Regulation (EU MDR).
• Prepare General Safety and Performance Requirements (GSPR) checklists.
• Assist with US FDA 510(k) submissions.

Official references for preparation:

• European Commission – Medical Devices Regulations
• US FDA – Premarket Notification 510(k)

C. Risk Management and Product Documentation

• Maintain risk management files according to ISO 14971.
• Collect and maintain test evidence related to IEC 60601-1, IEC 60601-1-2 and ISO 10993.
• Review product labels, Instructions for Use (IFUs) and Unique Device Identification (UDI) data.

D. Quality Management and Post-Market Activities

• Support ISO 13485 Quality Management System (QMS) activities.
• Assist with document control, Corrective and Preventive Actions (CAPA), change control and audits.
• Support post-market surveillance and complaint handling.
• Assist with Materiovigilance Programme of India (MvPI) reporting.

4. Eligibility Criteria and Required Skills

Candidates should have relevant medical device regulatory affairs experience and familiarity with applicable regulations, quality systems and technical documentation.

Educational Qualification: A specific mandatory educational qualification has not been mentioned in the available job description. Candidates should check the official listing for any additional requirements.

5. Important Regulatory Standards to Prepare

Candidates preparing for the Ayati Devices Regulatory Affairs Associate position should be familiar with the following regulations and standards relevant to medical device compliance and documentation.

Understanding these standards can help candidates prepare for the technical responsibilities associated with this role and relevant regulatory affairs interview questions.

6. Resume Preparation Tips for This Position

A resume for this opportunity should clearly demonstrate practical medical device regulatory affairs knowledge.

If applicable, highlight experience in the following areas:

• CDSCO applications and SUGAM portal submissions.
• Preparation and maintenance of Device Master Files (DMF) and Plant Master Files (PMF).
• EU MDR technical documentation and GSPR checklists.
• ISO 13485 quality management system activities.
• ISO 14971 risk management documentation.
• CAPA, change control and document control.
• Medical device labelling, IFU and UDI review.
• Complaint handling and post-market surveillance.

Practical tip: Avoid listing every regulatory standard simply to match the job description. Mention your actual responsibilities, documents handled and relevant project experience. This helps recruiters understand your level of practical exposure.

7. How to Apply for Ayati Devices Regulatory Affairs Associate Job

Interested candidates should follow the application instructions provided in the official Ayati Devices recruitment listing.

As mentioned in the job description, candidates are requested to submit their CV along with the following details:

1. Current CTC.
2. Expected CTC.
3. Notice period.

Required Email Subject: Regulatory Affairs Associate

Use the exact subject line “Regulatory Affairs Associate” when submitting your application.

Important: The available job information does not specify a recipient email address. Check the official recruitment listing for the correct email address and submission instructions before sending your CV.

Official Job Link: Regulatory Affairs Associate – Ayati Devices | View Job & Apply

Visit Ayati Devices Careers to explore other opportunities.

8. Explore More Pharma Jobs and Career Resources

Looking for other opportunities and preparation materials? Explore these resources on Pharma Career Updates:

• Latest Regulatory Affairs Jobs
• Career in Regulatory Affairs After B.Pharm
• Government Jobs After B.Pharm
• Free Regulatory Affairs Mock Test with Certificate
• Explore All Pharma Job Categories

9. Frequently Asked Questions

1. What position is available at Ayati Devices Private Limited?

Ayati Devices has listed an opening for a Regulatory Affairs Associate.

2. Where is the job location?

The position is based in Bengaluru North, Karnataka, India.

3. How much experience is required?

Candidates should have 1–2 years of hands-on regulatory affairs experience in the medical device industry.

4. What regulatory knowledge is required for this position?

Working knowledge of Medical Devices Rules, 2017, ISO 13485 and ISO 14971 is required. Exposure to EU MDR, US FDA or ASEAN regulations is an advantage.

5. Is this a pharmaceutical or medical device regulatory affairs role?

This is specifically a medical device regulatory affairs position. The responsibilities include CDSCO submissions, international technical documentation, risk management and quality management systems.

6. What details should candidates include when applying?

Candidates should submit their CV along with their current CTC, expected CTC and notice period. The required email subject is “Regulatory Affairs Associate”.

7. Is the educational qualification specified?

The available job description does not mention a specific mandatory educational qualification. Candidates should check the official listing for any additional requirements.

8. Where can candidates find other Ayati Devices vacancies?

Candidates can visit the official Ayati Devices Careers Page to check other available positions.