Work Flexibility: Hybrid

We are currently seeking a Regulatory Affairs Specialist to join our team Hybrid, in Waterdown, ON.

What you will do

The Regulatory Affairs Specialist is 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.

Develops and executes local regulatory strategies for all license applications. Seeks guidance from Senior RA Specialists and/or RA Manager as required.Authors medical device applications (Class II, III, and IV) to Health Canada. Seeks guidance from Senior RA Specialists and/or RA Manager as required.Collaborates with manufacturers to strategically address application deficiencies in accordance with the timeline dictated by Health Canada.Assesses post-market product changes to determine if the changes impact the device license. Develop and execute plan with cross-functional partners (Operations, Marketing, etc.) to manage any business impact. Seeks guidance from Senior RA Specialists and/or RA Manager as required.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.Review marketing material to ensure adherence to applicable regulatory requirements.Prepare annual license renewal applications and submit to Health Canada in accordance with the timelines dictated by Health Canada.Prepare certification renewal applications (ex. MDEL) in accordance with the timelines dictated by Health Canada.Establishes and cultivates a wide range of collaborative business relationships to facilitate completion of assignments.Stay abreast of regulatory procedures, evolving regulations and guidelines and changes in the regulatory climate.In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Completes other regulatory activities as assigned by manager.Working knowledge of Canadian Medical Device Regulations. Knowledge of Health Canada regulations for Drugs, and Cells, Tissues, and Organs a benefit. Proficiency with Microsoft Office and Document Management Systems.Demonstrated time management skills and the ability to prioritize and handle multiple projects is required.Excellent analytical, communication and interpersonal skills.Seeks out diverse ideas, opinion, and insights and applies them in the workplaceConnects and relates well with people who think and act differently than oneselfEmbraces scrutiny and accepts feedback as opportunity to learn and improveChooses the best alternative to achieve desired outcome or effect, considering risks, tradeoffs, timing, and available resources.

What you need

A minimum of a University Degree required.A Post Graduate Diploma in Regulatory Affairs or Quality Assurance preferred.A minimum of 2 years of experience in a regulatory affairs and quality assurance environment preferred.A minimum of 1 year of experience working in the Medical Device sector preferred.Internal applicants with an equivalent combination of education, experience, and performance over time at Stryker will be considered.Abide by and support the policies set forth in the Stryker Code of Conduct.Understand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with Stryker.Conduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standards.Report any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker’s Ethics Hotline Policy.

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