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Open nowPosted yesterday

REGULATORY AFFAIRS INTERN

gehc1,075 open roles

Where
Mississauga
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Your applicationOpen nowREGULATORY AFFAIRS INTERNgehc · Mississauga

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The clock on this job

Early applications get read.

13.8% of postings close within 7 days. Measured by our own scanner across the market. gehc postings stay open a median of 18 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.8%7 days
  4. 22.3%14 days
  5. 37.8%30 days
  6. 59.0%60 days
This job: posted yesterday

gehc median: 18 days open

The posting

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

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