Regulatory Affairs Intern

12 hours ago

Mississauga, Canada GE Healthcare Full time

**Job Description Summary**: 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**:

- ** 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.**:

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

- ** Support regulatory inspections as required.**:

- ** Establish plan and deliverables for timely submission of annual medical device licence and establishment licence renewal.**:

- ** File and maintain regulatory deliverables.**:
**Required Qualifications**:

- ** Strong analytical skills**:

- ** Ability to work in a team environment with mínimal supervision on projects and activities.**:

- ** Ability to prioritize, plan & evaluate deliverables.**:

- ** Knowledge & experience conducting scientific, regulatory, legal, or business research.**:

- ** Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner.**:
**Preferred Qualifications**:

- ** Experience in medical device industry.**:

- ** Knowledge of Quality Management Systems (QMS).**:

- ** Experience working across cultures/countries/sites.**:

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

- ** Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.**:

- ** Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.**:
**The Regulatory Affairs Intern role is a 1-year contract.**:
**Additional Information**:
**Relocation Assistance Provided**:No

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