Surbhi Sinha

Experience

1. Senior Executive Product Surveillance

   Vantive

   Feb 2025 — Present · Gurugram, IN

   Following the company split, I transitioned from Baxter to Vantive, continuing in my same role as Sr Executive, Product Surveillance to support the new organization’s growth and innovation.As a Regulatory Affairs professional specializing in Post Market Surveillance under EU MDR, I have led gap assessments, implemented regulatory requirements, and maintained key PMS documents, including PSUR, PMS Plan, and PMS Report.I collaborate with cross-functional teams to ensure compliance, analyze complaint and product failure data, and manage regulatory reporting to Competent Authorities. I have also driven Active Market Surveillance and streamlined PMS processes for efficiency and compliance.With experience in APAC complaint management and Track-wise monitoring, I ensure QMS adherence to internal and external regulations. Passionate about regulatory compliance and patient safety, I am eager to contribute to your organization’s success.

Education

• Delhi University

  Bachelor of Science - B.Sc (H), Microbiology

  2011 — 2014

• Indian Institute of Management Bangalore

  Certification Course , Operations Management

  2019 — 2019

• Banaras Hindu University

  Master of Science (M.Sc.), Applied Microbiology

  2014 — 2016