Key Responsibilities:
Prepare, review, and maintain regulatory documentation in accordance with Medical Device Rules (MDR), 2017 and applicable CDSCO guidelines.
Compile and submit applications for medical device registrations, manufacturing licenses, import licenses, and other regulatory approvals through the CDSCO portal.
Coordinate with internal teams and clients to collect, review, and validate regulatory documentation required for submissions.
Monitor submission timelines and ensure timely responses to regulatory queries and deficiency letters issued by CDSCO.
Interpret Indian medical device regulations and provide regulatory guidance to internal stakeholders and clients.
Assist in preparing technical documentation, labelling reviews, declarations, and other compliance-related documents.
Support post-approval regulatory activities, including license amendments, renewals, and change notifications.
Keep track of updates in CDSCO regulations, Medical Device Rules, guidance documents, and applicable Indian standards.




Coordinate with project teams to ensure regulatory compliance throughout the product lifecycle.
Maintain accurate regulatory records and documentation in accordance with internal quality management systems.
Qualifications:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Biotechnology, or a related discipline.
2–4 years of experience in Medical Device Regulatory Affairs.
Hands-on experience in CDSCO regulatory submissions for medical devices.
Experience working with the Medical Device Rules (MDR), 2017.
Knowledge of the CDSCO online portal and regulatory submission process.
Understanding of medical device classification, licensing requirements, and applicable Indian regulatory frameworks.
Familiarity with ISO 13485 and ISO 14971 will be an added advantage.
Excellent documentation, communication, and coordination skills.
Robust analytical, organisational, and problem-solving abilities.
Ability to manage multiple projects

📌 Regulatory Executive (Ahmedabad)
🏢 Maven Profcon Services
📍 Ahmedabad