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Regulatory Affairs
- Location Oakville
- Job type Contract
- Salary CA$1 - CA$30 per hour
- Discipline Advanced Manufacturing
- Reference JOB-19552_1629129797
Contract Role: Regulatory Affairs Professional
Constract Duration: 08/30/2021 to 08/26/2022
Contract Location: Oakville, ON
Position Summary:
Needs professional technological, economical or scientific know how, methods, tools and principles, and applies to differing and variable situations.Needs to solve assigned, non-routine tasks, to contribute to projects or assignments, or to support development of guidelines, methods, tools or business processes. Good knowledge in a technical field or business method including the basic theoretical background. Develops basic business understanding. Contributes to team effort, awareness of expected value add. May improve processes, business methods or technical components
Description:
- Analyzes the requirements and prepares product related regulatory submissions
- Creates quality guidelines and work instructions relevant for maintaining regulatory compliance
- Identifies, analyzes and implements country specific requirements necessary for product related submissions
- Plans and prepares product related submissions with internal (e.g. Regional Units) or external organizations according to regulatory requirements
- Performs regulatory projects or acts as a member of the project steering group
- Submits required documentation/information to local authorities or internal
- Initiates and escalates necessary activities if deviations are identified
- Ensures creation of adequate documentation for audits/inspections
- Performs training within the organization in country specific regulatory requirements, if applicable
- Performs review of promotional material for regulatory compliance according to country specific requirements
- May represent the company in industry associations (Lobbying), if applicable
Required Experience
- 2+ years or Master Entry