Nimit Shah

About Nimit Shah

A highly motivated, enthusiastic Regulatory leader, experienced in the field of Regulatory Affairs Quality Compliance for Medical Device Industries. Career Summary:• 10+ years of Medical Device Regulatory experience with Master’s Degree in Regulatory Affairs• Extensive Knowledge of Interpreting Regulations for Software, Electrical, Radiation Containing Medical Devices• Managing and leading team of regulatory engineers/specialists, ensuring compliance to regulatory processes and requirements to deliver medical devices to patients in timely manner.• Led regulatory submissions through strategy to address agency concerns (FDA, Notified Body, China NMPA)• Competent in delivering regulatory strategies for US, EU, China, Korea, Russia and other markets for NPI projects• Planning and Managing Global Product Registration for NPIs and Significant Design Changes• Experienced in Design Control, Regulatory Standards, FDA Guidance and its implementation within business• Working with Regulatory Agency for Audits (FDA, EU, Internal Audits), direct communication with auditors• Mentorship, Coaching to juniors and new hires within Regulatory Team, supporting career development opportunities for direct reports• Excellent communication, negotiations skills, ability to work with regulatory agency (FDA, EU, China, Canada)

Experience

1. Sr Manager Regulatory Affairs

   Philips

   Aug 2022 — Present

   Leading a team of Regulatory Engineers, Labelling, Tech Writers at for Respiratory Category.

Education

• Gujarat Technological University (GTU)

  Bachelor's degree, Pharmacy

• Northeastern University

  Master's degree, Regulatory Affairs for Drugs, Biologics, Medical Devices