Intern

Beschreibung:

ZEISS in India

ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics.

ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS' success story in India is continuing at a rapid pace.

Further information at ZEISS India.

To support execution of regulatory submissions, documentation, and country communications for global medical device projects under guidance of the RA Project Manager, ensuring compliance with applicable regulations and timely deliverables.

Documentation Preparation
* Prepare and update regulatory documents including:
* STED sections
* GSPR checklists
* DoC drafts
* Change notifications and CIA documentation
* Support claims matrix updates and labeling documentation.

Country Communications & Registrations
* Execute country-specific submissions and notifications.
* Track registration status and authority timelines.
* Maintain MRA records and release documentation in SAP/eDMS.

Regulatory Impact Support
* Assist in reviewing ECRs and supporting impact assessments.
* Support preparation of NPA documentation and change classification checklists.

PMS & Lifecycle Support
* Maintain PMS documentation (PSUR, PMS plans).
* Support audit documentation preparation.

Cross-Functional Coordination
* Work with QA, Clinical Affairs, and Product teams to gather required documentation.
* Participate in internal RA review meetings.

Data & Process Management
* Maintain regulatory trackers and dashboards.
* Support digital RA tools (e.g., Polarian workflow updates).

Your ZEISS Recruiting Team:Kharan Basumatary