Senior Executive / Manager Product Registration & Product Development

Job Purpose

To manage and execute CDSCO medical device registrations and licenses in India, ensuring full compliance with the Medical Devices Rules (MDR), 2017 and maintaining regulatory approvals throughout the product lifecycle.

Key Responsibilities

CDSCO Registration & Licensing

- Prepare, compile and submit CDSCO applications for medical devices (Class A, B, C, D).
- Handle applications for Manufacturing License, Import License, Loan License and Registration Certificates.
- Prepare and submit applications via Sugam / CDSCO online portal.
- Coordinate with CDSCO officials and State Licensing Authorities (SLA) for queries, inspections and approvals.
- Track application status and ensure timely approvals and renewals.

Regulatory Documentation

- Prepare and maintain Device Master File (DMF) and Plant Master File (PMF) as per MDR 2017.
- Ensure accuracy of technical documentation, labeling, IFU and declarations.
- Support risk management files, clinical evaluation reports and performance data as required by CDSCO.
- Maintain records for post-approval changes, variations, and amendments.

Compliance & Lifecycle Management

- Ensure ongoing compliance with Medical Devices Rules, 2017 and CDSCO guidelines.
- Manage license retention, renewal and endorsement activities.
- Support post-market surveillance,



vigilance reporting and field safety corrective actions (FSCA).
- Monitor regulatory updates, notifications and guidance issued by CDSCO.

Audit & Inspection Support

- Support CDSCO, SLA and internal audits and inspections.
- Assist in responding to deficiency letters and show-cause notices.
- Maintain inspection readiness and regulatory records.

Qualifications

- Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences, Biotechnology or related field.
- Regulatory Affairs certification is an added advantage.

Experience

- 1–5 years of hands-on experience in CDSCO medical device registration.
- Practical experience using the Sugam portal is mandatory.

Skills & Knowledge

- Solid knowledge of Medical Devices Rules (MDR), 2017
- Experience in DMF, PMF and CDSCO online submissions
- Familiarity with device classification and risk-based approach
- Good communication and coordination skills
- High attention to detail and documentation accuracy

Preferred Skills

- Experience with Import License (Form MD-14 / MD-15 / MD-17)
- Experience with manufacturing license (Form MD-9 / MD-5)
- Experience handling Class B, C or D medical devices
- Knowledge of ISO 13485 and basic quality systems

Key Performance Indicators (KPIs)

- On-time CDSCO approvals and renewals
- Zero major regulatory non-compliances
- Successful audit outcomes
- Accuracy of regulatory documentation

📌 Senior Executive / Manager (Chennai)
🏢 Cnergy Incorporation
📍 Chennai