Regulatory Affairs Intern (Immediate Start)

Job description

3192588
Additional Cities

Mississauga
Career Level

Co-op/Intern
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

Canada
Additional States/Provinces

Ontario
Postal Code

L5N 5P9
Role Summary/Purpose

Position Title: Regulatory Affairs Intern
GE Business: GE Healthcare
Location: Mississauga, ON
Duration: 6-8 Months
Anticipated Start Date: Immediate Start
Number of positions: 1

Essential Responsibilities

The Position:

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. He/she ensures accurate and optimal medical device regulatory submissions that meet or exceed Health Canada requirements. 

Your specific goals in this role are as follows:
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Completing all planned Quality & Compliance training within the defined deadlines;
• Identifying and reporting any quality or compliance concerns and take immediate corrective action as required;
• Ensuring assigned regulatory submissions are accurate, complete, and timely;
• Maintaining up-to-date knowledge and understanding of current regulatory requirements within your area of responsibility.

Nature of work:

In this role, your responsibilities will include (but are not limited to);
• Creating regulatory compliance/project plans to ensure all requirement are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions;
• Supporting regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance, and improvement of documented processes;
• Supporting regulatory inspections as required;
• Reviewing advertising and promotion materials for country or regional compliance and approve these as required;
• Establishing a plan and deliverables for timely submission of annual medical device license and established license renewal;
• File and maintain regulatory deliverables.

Qualifications/Requirements

Do you qualify? We are seeking… 

Skills:
• Individuals with less than 2 years of work experience (outside of co-op/internship/summer work experience);
• Strong analytical skills;
• Ability to work in a team environment with minimal supervision on projects and activities;
• Ability to prioritize, plan, and 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;
• Experience using spreadsheets and presentation software.

Education:
• University Bachelor or Master’s Degree (or internationally recognized equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, Life Sciences
• Completion of postgraduate Regulatory Affairs program OR Bachelor’s Degree and minimum 1 year regulatory affairs experience in the medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations.

Candidates are to submit a cover letter and resume. It is a mandatory requirement that you identify your school, cumulative GPA, and anticipated graduation date as part of the application process.

Please note that this position does not provide a subsidy for relocation expenses.

Only those selected for an interview will be contacted. Thank you for your interest in joining GE.
Desired Characteristics

Desired:
• Experience in the medical device or pharmaceutical industry;
• Regulatory Affairs Certification (RAC);
• 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 the healthcare environment and knowledge of current competitive, commercial, or political situations and their impact on GEHC regulatory strategies.

About Us

GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

GE Healthcare:
What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our 'healthymagination' vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world. As a global leader, GE can bring together the best in science, technology, business, and people to help solve some of the world's toughest challenges and shape a new age of healthcare. For more information about GE Healthcare visit our websitehttp://www.gehealthcare.com .

Want to know what we’re working on at GE Canada? Visitwww.gereports.ca .

GE Canada is recognized as one of the Top Employers for Young People in 2017. To learn more about our Campus program please go to:www.campuscareers.ge.ca
Twitter: @GECanadaCampus

GE – imagination at work
An Equal Opportunity Employer

Primary Country

Canada
Primary State/Province

Ontario
Primary City

Mississauga