Job Title:

DGM-Regulatory- Device

Business Unit:

GDO

Job Grade

G8

Location :

Gurgaon/Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an setting 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 collaborative 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.
- Manage preparation, review, and submission of regulatory dossiers, including: 510(k), PMA, Medical Device License applications, CE marking submissions, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE) submissions ensuring accuracy, consistency, and regulatory compliance of all submissions.
- 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.

📌 DGM - Regulatory Expert Medical Device (India)
🏢 Sun Pharmaceutical
📍 India