Regulatory Intern

2 weeks ago


Buffalo, United States Nissha Medical Technologies Full time
Job Summary

Regulatory Intern will be able to learn about the responsibilities of a Regulatory Department within a global Medical Device Business. This is a great opportunity for anyone looking to have a career in Regulatory, Quality and has an interest in Medical Device regulatory compliance. You will focus on becoming familiar with international Medical Device Regulatory compliance requirements, with a special focus on Post Market Surveillance activities. As a part of the regulatory team, you will execute Post Market Surveillance data collection and prepare the related evaluations.

Essential Job Functions
  1. Execute Post Market Surveillance data collection for several Product Families according to individual Post Market Surveillance Plans
  1. Collaborate with team members in Sales / Customer Service and Quality to collect internal data for Post Market Surveillance
  1. Review and update our internal data sharing system "Global Regulatory Database" to ensure that Sales / Customer Service is provided with up-to-date regulatory documentation for international sales.
  1. Assist with building framework for documentation related to regulatory requirements for different product families.
  1. Work with Quality staff members to ensure data collection and documentation is present as per global material compliance regulations and internal procedures.
  1. Help collect/ transfer data related to supplier controls and monitoring activities.
  1. Additional functions related to ensuring regulatory documentation is prepared/ inputted related to requirements outlined in the Quality Management System.


Requirements
  • Student currently enrolled in a bachelor's degree in a related public health, engineering, science, or life science field
  • Strong desire and motivation to develop a career in public health policy or regulatory operations.
  • Willingness to learn about manufacturing processes and quality assurance through daily activities.
  • Ability to work independently
  • Strong verbal and written communication
  • Willingness to learn, be mentored, and improve by accepting candid feedback

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