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Sr Specialist Reg Affairs

3 months ago

Bengaluru, Karnataka, India Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

This position will be responsible for supporting all regulatory activities associated with product development, new registrations and optimal lifecycle management of Kidney Care's current portfolio of Peritoneal Dialysis cyclers. This position will interface with key business and cross-functional stakeholders to ensure that the commercial objectives are achieved. Specific activities may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project teams.

This is an important position within the Kidney Care Regulatory Team and is accountable for the relationship with the US Food and Drug Administration, EU Notified Bodies, along with other relevant regulatory organizations. It provides input and helps influence global regulatory strategies and is responsible for the local execution of Baxter's regulatory initiatives in line with business goals.

Key Responsibilities

Identify Regulatory plan for Electromechanical and software products Identify applicable Regulations and standards (for Electromechanical devices ,software and network connected devices) Identify product Requirements, labelling requirements and Compliance requirements Provide Regulatory inputs for cross functional teams Plan Regulatory activities required for every product milestone Review, edit and proofread regulatory documentation Prepare Regulatory dossiers for submissions (EU MDR STED, 510k) Determine submission strategy and provide estimates for program schedule Participate in Risk management and provide inputs required to comply with Regulatory Requirements Review product DHF, Assess Regulatory impact for Changes to product To manage end to end Change process for RA Participate in audits representing Regulatory function Coordinate with Regulatory Authorities and respond to any questions Coordinate with in-Country RAs for submission, Registration, Renewal, EOL & Geo-Expansion activities Identify and mitigate Regulatory Risks Obtain Regulatory Clearances in Target countries Communicate Regulatory clearance and maintain Regulatory approvals Maintain regulatory files in a format consistent with requirements