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Regulatory Affairs Specialist

2 months ago

Hamilton, Ontario, Canada Stryker Canada ULC Full time
Job Overview

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.

Key Responsibilities
  • Collaborate with internal teams/departments to promote a culture of inclusiveness and cooperation.
  • Develop and execute local regulatory strategies for market authorizations in Canada. Seek guidance from Senior RA Specialists and/or RA Manager as required.
  • Author applications to Health Canada for drugs, natural health products, and cosmetics in compliance with the applicable regulations. Seek guidance from Senior RA Specialists and/or RA Manager as required.
  • Collaborate with manufacturers to strategically address application deficiencies in accordance with the timeline dictated by Health Canada.
  • Assess 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. Seek guidance from Senior RA Specialists and/or RA Manager as required.
  • Plan and organize project assignments and maintain project schedules in accordance with the business plan. Communicate progress to plan, risks, and needs to appropriate business functions.
  • Review marketing material to ensure adherence to applicable regulatory requirements.
  • Prepare registration renewal applications (ex. Drug Establishment Licence and NHP Site Licence) in accordance with the timelines dictated by Health Canada.
  • Establish and cultivate 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, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Complete other regulatory activities as assigned by manager.
Conduct & Compliance
  • Avoid any actions that may compromise the integrity of Stryker Canada ULC.
  • 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.
Knowledge & Skill Requirements
  • 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.
  • Seek out diverse ideas, opinion, and insights and apply 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.
Education & Qualifications
  • 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.