About this role
# 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