Specialist, Regulatory Affairs

at  Stryker

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

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
  Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually

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.
• 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 resource

INDIVIDUAL 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,

Functional Responsibilities:

• 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.,. 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 market authorization. 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 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.
• 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

Conduct & Compliance

• 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

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.
• 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