Regulatory Affairs Intern - Mississauga, Canada - GE Healthcare

GE Healthcare

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Job Description Summary

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The Regulatory Affairs Intern will be involved in Premarket and Compliance duties.

They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket support.

Key responsibilities/essential functions include

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Create regulatory compliance / project plan to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions

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Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes

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Support regulatory inspections as required

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Establish plan and deliverables for timely submission of annual medical device licence and establishment licence renewal

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File and maintain regulatory deliverables

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Required Qualifications

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Strong analytical skills

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Ability to work in a team environment with mínimal supervision on projects and activities

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Ability to prioritize, plan & evaluate deliverables

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Knowledge & experience conducting scientific, regulatory, legal, or business research

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Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner

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Preferred Qualifications

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Experience in medical device industry

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Knowledge of Quality Management Systems (QMS)

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Experience working across cultures/countries/sites

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Demonstrated experience interfacing with regulatory agencies (e.g. Health Canada, FDA)

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Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment

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Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies

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The Regulatory Affairs Intern role is a 1-year contract

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Additional Information

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Relocation Assistance Provided

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No