Himangi Batra
post-market surveillance for medical devices @vantive|biotechnology| intern @ NDRI
- Role
- Post Market Suvilence in Medical Devices at Vantive
- Location
- Jind, HR, IN
- LinkedIn followers
- 500 followers
About Himangi Batra
Managed Post Market Surveillance (PMS) activities for renal & peritoneal dialysis medical devices in compliance with EU MDR (2017/745). • Performed complaint handling including intake, triage, investigation coordination, root cause analysis and closure within defined timelines. • Prepared and submitted MDR (Medical Device Reports) and MIR (Manufacturer Incident Reports) to competent authorities as per regulatory requirements. • Conducted global safety surveillance (GSP tasks) including adverse event trending, signal detection and risk evaluation. • Supported task transfer activities ensuring smooth transition of PMS and complaint handling processes with complete documentation and training. • Maintained and updated PMS documentation, including complaint records, vigilance reports, trend analysis and periodic safety inputs. • Performed data handling and analysis to identify complaint trends, safety signals and potential risks impacting patient safety. • Collaborated cross-functionally with Quality, Regulatory Affairs, Clinical and R&D teams for investigations and corrective actions. • Ensured timely compliance with reporting timelines and internal SOPs for vigilance and post-market activities. • Assisted in preparation of inputs for PSUR / PMSR and regulatory inspections or audits.
Experience
Post Market Suvilence in Medical Devices
Feb 2025 — Present · Gurugram, IN
Baxter kidney Care is now Vantive-a new standalone company dedicated to advancing vital organ therapies. I\'m incredibly proud to be a part of this new chapter, building on a 70-year legacy of kidney care leadership and innovation.At Vantive, our mission is clear: to extend life and expand possibilities for patients and care teams everywhere.Follow us on this exciting journey as we continue to push the boundaries of what\'s possible in healthcare.Follow @VantiveHealth and learn more at Care#PatientCare#Organ Therapies
Education
Kurukshetra University (KUK)
Bachelor of Education - BEd, Human Resources Management/Personnel Administration, General
Deenbandhu Chhotu Ram University of Science & Technology
Bachelor of Technology - BTech, Biotechnology
Deenbandhu Chhotu Ram University of Science and Technology (DCRUST), Murthal
Master's degree , Biotechnology
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