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Regulatory Affairs Specialist
1 month ago
This position is responsible for assisting in Stryker Canada's Regulatory compliance activities for the commercialization of healthcare products with a focus on drug, natural health products, and cosmetics. This individual must serve as a contributing member of the Regulatory Affairs team while championing Stryker's Mission and Values.
Responsibilities- Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation
- Responsible for living and exemplifying Stryker's Values: Integrity, Accountability, and Excellence
- Develops and executes local regulatory strategies for market authorizations in Canada. Seeks guidance from Senior RA Specialists and/or RA Manager as required.
- Authors applications to Health Canada for drugs, natural health products, and cosmetics in compliance with the applicable regulations.
- 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 market authorization. Develop and execute plan with cross-functional partners (Operations, Marketing, etc.) 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.
- Reviews marketing material to ensure adherence to applicable regulatory requirements.
- Prepares registration renewal applications (ex. Drug Establishment Licence and NHP Site Licence) in accordance with the timelines dictated by Health Canada.
- Establishes and cultivates a wide range of collaborative business relationships to facilitate completion of assignments.
- Stays 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
- Abides by and supports the policies set forth in the Stryker Code of Conduct
- Understands 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
- Conducts work in compliance with all laws, rules, and regulations and in accordance with Stryker's high ethical standards
- Reports any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker's Ethics Hotline Policy
- Working Knowledge of Health Canada regulations for Drugs, NHPs, Cosmetics. Knowledge of Canadian Medical Device Regulations and Cells, Tissues, and Organs Regulations 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 workplace
- Connects and relates well with people who think and act differently than oneself
- Embraces scrutiny and accepts feedback as opportunity to learn and improve
- Chooses the best alternative to achieve desired outcome or effect, considering risks, tradeoffs, timing, and available resources
- A minimum of a University Degree required.
- Post-Graduate Diploma in Regulatory Affairs or Quality Assurance completed or in process an asset.
- A minimum of 2 years of experience in a Regulatory Affairs role preferred.
- Internal applicants with an equivalent combination of education, experience, and performance over time at Stryker will be considered
