Job Description Summary
The Regulatory Affairs Intern will gain hands-on experience supporting premarket and compliance activities within a collaborative Regulatory Affairs team. The intern will contribute to regulatory projects and help establish and implement best-practice processes and procedures that support efficient premarket activities and regulatory compliance.
Job Description
GE HealthCare is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to support our regulatory team in ensuring compliance with Canada Medical Devices Regulations. This role offers a unique opportunity to gain hands-on experience in the medical device industry.
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:
•Bachelor’s Degree in a related field such as: Biomedical Engineering, Biology, Chemistry, Life Sciences, and completion of postgraduate Regulatory Affairs program OR Bachelor’s Degree and minimum of 1 year regulatory affairs experience in medical device industry or medical product regulation agencies, including knowledge and experience applying device laws and regulations.
•Strong analytical skills
•Ability to work in a team environment with minimal 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.
Additional Information
Relocation Assistance Provided: No