Regulatory Affairs Executive - Medical devices

DSS Imagetech Pvt Ltd; Delhi; On-site; INR 600,000 - 900,000; Full time

Job summary

DSS Imagetech Pvt. Ltd. in Delhi seeks a Regulatory Affairs Executive with hands-on medical device regulatory experience to manage registrations, submissions, licensing, and compliance for the Indian portfolio.

You will coordinate with international manufacturers, regulatory consultants, and authorities to ensure timely approvals and ongoing compliance. Responsibilities include preparing and maintaining submissions, reviewing technical docs, and monitoring regulatory changes.

Qualifications

• Graduate/Postgraduate in Pharmacy, Biotechnology, Biomedical Engineering, Medical Technology, Life Sciences or relevant technical discipline.
• 2-5 years of relevant experience specifically in Medical Device Regulatory Affairs.
• Hands-on experience with CDSCO, Medical Devices Rules (MDR), 2017, and Indian medical-device registration processes.
• Experience coordinating with international medical-device manufacturers/principals is advantageous.
• Strong documentation, analytical, coordination and communication skills.

Responsibilities

• Manage regulatory registration and licensing activities for medical devices in India.
• Prepare, compile, review, and maintain regulatory submissions and supporting documentation.
• Coordinate with international manufacturers/principals to obtain technical and regulatory documentation.
• Handle new product registrations, renewals, amendments, and other regulatory submissions.
• Support CDSCO submissions and regulatory correspondence.
• Ensure compliance with Medical Devices Rules (MDR), 2017 and related regulatory requirements.
• Support product classification and determine applicable regulatory pathways for new devices.
• Review technical documentation, declarations, certificates, labels, IFUs, and other documents.
• Maintain regulatory databases, registrations, licences, certificates, and submission trackers.
• Coordinate with regulatory consultants and authorities for queries, inspections, and approvals.
• Monitor changes in Indian medical device regulations and assess impact on portfolio.
• Support regulatory requirements for new devices and technologies in India.
• Coordinate with Quality, Supply Chain, Product Management, Sales on regulatory needs.
• Support post-approval activities including renewals, variations, and regulatory updates.
• Ensure regulatory documentation is accurate, complete, and traceable.

Skills

Medical Devices

Regulatory Affairs

CDSCO

MDR 2017

Medical Device Registration

Import Licence

Regulatory Submissions

Product Classification

Technical Documentation

Device Master File

Plant Master File

Essential Principles

Labeling

IFU

Regulatory Compliance

Product Registration

Regulatory Tracking

International Coordination

Documentation Management

Education

Graduate/Postgraduate in Pharmacy, Biotechnology, Biomedical Engineering, Medical Technology, Life Sciences

Job description

Regulatory Affairs Executive - Medical Devices

Company: DSS Imagetech Pvt. Ltd.

Location: Delhi

Function: Regulatory Affairs

Industry: Medical Devices

About the Role

DSS Imagetech Pvt. Ltd. is looking for a Regulatory Affairs Executive with hands-on experience in the medical device industry to manage and support regulatory registrations, submissions, licensing, and compliance activities for our medical device portfolio in India.

The role will involve working with international manufacturers, internal teams, regulatory consultants, and Indian regulatory authorities to ensure timely product registrations and ongoing regulatory compliance.

Key Responsibilities

• Manage regulatory registration and licensing activities for medical devices in India.
• Prepare, compile, review, and maintain regulatory submissions and supporting documentation.
• Coordinate with international manufacturers/principals to obtain technical and regulatory documentation.
• Handle new product registrations, renewals, amendments, and other regulatory submissions.
• Support CDSCO submissions and regulatory correspondence.
• Ensure compliance with applicable requirements under the Medical Devices Rules (MDR), 2017 and related regulatory requirements.
• Support product classification and determine applicable regulatory pathways for new medical devices.
• Review technical documentation, declarations, certificates, labels, IFUs, and other product-related regulatory documents.
• Maintain regulatory databases, product registrations, licences, certificates, and submission trackers.
• Coordinate with regulatory consultants and authorities for queries, clarifications, inspections, and approvals.
• Monitor changes in Indian medical device regulations and assess their impact on the company's product portfolio.
• Support regulatory requirements for the introduction of new medical devices and technologies in India.
• Coordinate with Quality, Supply Chain, Product Management, Sales, and other internal teams on regulatory requirements.
• Support post-approval activities including renewals, variations, product changes, and regulatory updates.
• Ensure regulatory documentation is accurate, complete, traceable, and maintained within defined timelines.

Candidate Profile

• Graduate/Postgraduate in Pharmacy, Biotechnology, Biomedical Engineering, Medical Technology, Life Sciences, or a relevant technical discipline.
• 2-5 years of Relevant experience specifically in Medical Device Regulatory Affairs.
• Hands-on experience with CDSCO, Medical Devices Rules (MDR), 2017, and Indian medical-device registration processes.
• Experience in medical-device registration, import licensing, regulatory submissions, and documentation.
• Understanding of technical documentation and regulatory requirements for medical devices.
• Experience coordinating with international medical-device manufacturers/principals will be an advantage.
• Strong documentation, analytical, coordination, and communication skills.
• High attention to detail and ability to manage multiple regulatory activities simultaneously.

Key Skills & Competencies

Medical Devices, Regulatory Affairs, CDSCO, Medical Devices Rules, MDR 2017, Medical Device Registration, Import Licence, MD-14, MD-15, MD-3, MD-5, Regulatory Submissions, Product Classification, Technical Documentation, Device Master File, Plant Master File, Essential Principles, Labeling, IFU, Regulatory Compliance, Product Registration, Regulatory Tracking, International Manufacturer Coordination, Documentation Management.