Regulatory Affairs Specialist
7 days ago
We are currently seeking a Senior Regulatory Affairs Specialist to join our Global RAQA Division to be based in Waterdown, Canada.
As the Senior Regulatory Affairs Specialist, you are responsible for assisting in Stryker Canada’s Regulatory compliance activities for the commercialization of healthcare products. This individual must serve as a contributing member of the Regulatory Affairs team while championing Stryker’s Mission and Values.
What you will do- Develops and executes local regulatory strategies for all license applications and launch activities.
- Provides regulatory input and technical guidance on local regulatory requirements to product development teams. li>
- Authors and submits medical device applications (Class II, III, and IV) to Health Canada. li>
- Assesses post-market product changes to determine if the changes impact the device license. to manage any business impact.
- Plans and organizes project assignments and maintains project schedules in accordance with the business plan. Communicates progress to plan, risks, and needs to appropriate business functions.
- Provides input on regulatory-related issues associated with compliance and achieving the business plan.
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