Regulatory Affairs Specialist

Regulatory Affairs Specialist Location: Bangalore, Karnataka Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. 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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Senior Specialist for BRD Regulatory Affairs Job Description: 1.     Identify Regulatory strategy and support sustaining projects for Digital portfolio 2.     Prepare Regulatory dossiers for EU & US 3.     Provide submission deliverables for GeoX submissions 4.     Plan Regulatory activities for EU MDD and MDR compliance 5.     Obtain Regulatory Clearances in Target countries 6.     Coordinate with Regulatory Authorities and respond to any questions/deficiencies/clarification for products that are submitted for approval 7. Coordinate with in-Country RAs for submissions/Registrations, Renewals, EOL Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.