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Job Summary
This role is responsible for providing regulatory support for on-market products. You will be independently Plan, Organize and Execute, activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management,



process support, and participation in project sub-teams.
You will help accelerate the design and development cycle by collaborating across cross functional teams.
Will be guiding, supporting and mentoring the team who are part of engineering design, development, and V&V.;
This position is based out of Bangalore and reporting to the Manager – Systems - Patient Support Systems and Global Surgical Solutions divisions. You will need to work collaboratively with R&D; and cross functions.
What you’ll be doing
Review and provide regulatory impact assessments for changes
Support global submission deliverables for product variation submissions
Responsible for working with other parts of the regulatory organization to achieve desired results.
Execute global plans and regulatory submission deliverables for sustaining variations
Utilize regulatory knowledge to prepare submission deliverables that w

📌 Principal Specialist, Regulatory Affairs (Bengaluru)
🏢 Baxter International
📍 Bengaluru