Safety and Compliance Specialist

Job Responsibility: Full-time Department: Other (Not Listed)

Company Description

The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education. With a long tradition of ground breaking firsts and a purpose of “Transforming lives and communities through excellence in care, discovery and learning”, the University Health Network (UHN), Canada's largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers. UHN is a caring, creative place where amazing people are amazing the world.

Union: non-union Site: Toronto General Hospital Department : Biomedical Engineering Reports to: Manager, Clinical Engineer Grade: N0:09 Hours: 37.5 hours Salary: $79,186-$98,982 (To commensurate with experience and consistent with UHN compensation policy) Status: Permanent, Full-Time Closing Date: June 30, 2024

Position Summary

UHN is looking for a skilled, dynamic, and motivated Safety and Compliance Specialist to join our Medical Engineering Department. The Medical Engineering Department is an agile and vibrant team that is responsible for managing diverse medical equipment and technology across all sites and programs of UHN.

The Safety and Compliance Specialist will be an ambassador for promoting and ensuring medical device safety at UHN. Two key roles include: (1) ensuring compliance with applicable standards, primarily as it relates to the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) and (2) managing UHN's alerts and recall processes.

Duties

• Support UHN in the mandatory reporting to Health Canada of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) that involve a therapeutic product, in order to comply with regulations put in place through the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law). This involves:
  • Reviewing reported patient safety events and engaging inter-professional teams across UHN to identify ADRs and MDIs that meet the criteria for submission
  • Collecting necessary information for ADR and MDI reports to Health Canada
  • Submitting ADR and MDI reports to Health Canada
  • maintaining documentation related to the review and submission of ADR and MDI reports
  • Providing data and information in response to ad hoc information requests from internal stakeholders
  • Providing guidance on decisions that have institutional impact including notifications to patients or where the risk assessment identifies a moderate or high-risk ADR or MDI.
• Manage UHN's response to alerts and recalls issued by federal agencies, manufacturers, suppliers, and other groups for medical devices (equipment), consumable/disposable products, implanted devices, etc. This involves:
  • Overseeing UHN's centralized alert management software system
  • Communicating and coordinating with inter-professional teams responsible for evaluating and acting on alerts
  • Ensuring effective alert processing
  • Providing data and information in response to ad hoc information requests from internal stakeholders.
• Ensure that the processes needed for compliance with Vanessa's Law and alert and recall management are established and provide oversight for the implementation and maintenance of these processes. This includes required policies, procedures, communication strategies for both internal and external stakeholders (including patients, if applicable), and guidelines for risk assessment involved in the review of the notifications received.
• Support safety initiatives in the organization and the department through consultation and education of best practices, legislative requirements and policies related to safety, quality and regulatory compliance. This includes assessment of the use of medical devices in research or novel work and communication strategies related to this.
• Manage projects and initiatives designed to promote device safety, quality assurance, and compliance on a corporate and department-wide scale.
• Performing cross-functional and other responsibilities, as required and/or requested.

Qualifications

• Completion of a bachelor's degree- clinical backgrounds or engineering backgrounds are all encouraged to apply
• Six years of experience in the healthcare field, or relevant experience
• Previous experience in safety, quality and performance improvement methods or quality assurance and compliance of at least 5 years is preferred
• Experience working with clinicians is required
• Experience leading Quality Improvement initiatives within healthcare is preferred to allow the individual to immediately facilitate events based on their knowledge and experience
• Previous experience working with government or regulatory agencies (local, provincial or federal) or accreditation bodies is preferred, including but not exclusive of submissions or reports to these bodies and/or providing support for inspection or accreditation activities.
• Project management experience preferred, specifically project planning and implementation experience
• Demonstrated experience in facilitating a major change initiative in a healthcare environment
• Demonstrated change management skills (consulting, negotiating, influencing)
• Knowledge of hospital organizational structure and processes preferred
• Experience working with diverse stakeholders
• Demonstrated ability to handle multiple competing priorities in a deadline-driven environment
• Analytical ability with excellent attention to detail and critical thinking skills
• Excellent verbal and written communication and presentation skills
• Experience using Microsoft Office applications and online tools

Please attach your resume AND cover letter in one file in order to be considered

Additional Information

All applications must be submitted before the posting close date.

UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.

Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire. Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN's mandatory Vaccination Policy that is in effect.

UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.

We thank all applicants for their interest, however, only those selected for further consideration will be contacted.