Regulatory Affairs Leader Job
Job Description Job Attributes+
Mississauga, ON L5N 0C9, Canada
Job Description SummaryGE Healthcare is a medical technology and diagnostics business with a vision to become the leading innovator enabling precision health. With us, you can touch the lives of thousands of people globally and make every moment matter in your career. In this role you will be involved in Premarket and Compliance duties. They will work with a team of Regulatory Affairs professionals to ensure GE Healthcare (GEHC) establishes best practices in compliance with regulatory requirements. The Regulatory Affairs Leader will provide subject matter guidance and be involved with regulatory activities in areas such as medical device premarket submissions, post-market support, regulatory intelligence, regulatory requirements flow-down, advertising and promotion review, product labeling, and compliance. They will ensure accurate and optimal medical device regulatory submissions that meet or exceed Health Canada requirements.
Key Responsibilities include:
Provides regulatory input for product development to ensure compliance to regulatory requirements for Canadian market.
Develops registration strategies to guide submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and business priorities to ensure optimized sequencing for submissions.
Works with a cross functional team to prioritize, produce and submit applications to Health Canada for the purpose of obtaining authorization for market launch. Handles responses to regulator inquiries.
Assesses changes to existing products and determines the need for reporting or for new / amended licenses.
Supports timely renewal of Medical Device Licences and Medical Device Establishment Licence.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Supports regulatory inspections as required.
Ensures compliance with pre- and post-market product approval requirements.
Develops and revises policies and procedures, as required.
Bachelor's Degree and a minimum of 3 years demonstrated experience interfacing with regulatory agencies.
Ability to apply strong technical and analytical skills to recommend solutions.
Ability to prioritize and plan, working independently in a fast-paced environment with little supervision.
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.
Ideally 5 years plus of experience interfacing with regulatory agencies
Experience interfacing with Health Canada’s Medical Devices Directorate.
Experience working across cultures/countries/sites.
Postgraduate certification in Regulatory Affairs.
Regulatory Affairs Certification (RAC).
Quality Specific Goals:
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.
Complete all planned training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.
Relocation Assistance Provided: No
- regulatory affairs
- medical device
- business research
- ability to communicate
- product testing
- regulatory intelligence
- product development
- policies and procedures
- medical devices
- written communication
- regulatory submissions
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