Dgm - Regulatory - Device (Gurugram)

Dgm - Regulatory - Device (Gurugram)

09 Sep
|
Sun Pharmaceutical Industries
|
Gurugram

09 Sep

Sun Pharmaceutical Industries

Gurugram

Title:DGM - Regulatory - Device:
- Date: May 19, 2026
- Location: Gurgaon - R&D;
- Company: Sun Pharmaceutical Industries Ltd

Job Title:

DGM-Regulatory
- DeviceBusiness Unit:

GDOJob Grade
G8Location:

Gurgaon/MumbaiAt Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine?As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a team-oriented spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”Purpose of the Role

Responsible for managing regulatory strategy, submissions, and compliance activities for medical devices for key markets, United States, Canada, and European Union. The role supports new product development, market authorizations, and lifecycle management (LCM) for medical devices,



including combination products (drug device), companion diagnostics, while ensuring compliance with applicable regulations and ISO standards.

Key Responsibilities
- Develop, document, and maintain end‑to‑end regulatory strategies for medical devices across the key markets, ensuring alignment with product technology, intended use, risk classification, and business objectives.
- Maintain the dossiers by filing annual reports and manage post‑approval submissions and Lead change impact assessments for Design modifications, Manufacturing and process changes, Supplier and raw material changes, labeling changes by accurately assessing and classifying the changes and prepare and manage change submissions and notifications to agencies.
- Provide regulatory input on Human factors and usability engineering and assess regulatory adequacy of design and development documentation, Device verification and validation etc.
- Review and assess preclini

📌 Dgm - Regulatory - Device (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram

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