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 and work independently while meeting deadlines.

📌 Regulatory Executive - Medical Device CDSCO (Ahmedabad)
🏢 Maven Profcon Services
📍 Ahmedabad