GE Jobs | Regulatory Affairs Leader Jobs Employment In Mississauga, British Columbia

 Name of the Recruitment Agencies/Department – GE

Name of the Vacant Position – Regulatory Affairs Leader

Job Location – Mississauga, Ontario

Salary –  $ 59,429.00 Per Year

Jobs Type – Jobs In Canada

Job Description

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.

Required Qualifications:

• 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.

Preferred Qualifications:

• 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.

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