Quality Assurance and Regulatory Compliance Specialist
Signal 1 is on a mission to transform hospital care with AI. Formed out of a partnership between Layer 6, a world-leading applied AI company, and Unity Health Toronto, a hospital network in Ontario, Signal 1 provides hospitals with an end-to-end clinical AI solution. We have a secure cloud-based platform that ingests patient data, applies real-time AI models, and delivers them directly into clinical workflows. Our platform is built on a proprietary technology stack which provides superior model performance, model explainability tools and a real-time model monitoring capability. All of Signal 1's models are developed in close collaboration with clinicians.
We are looking for a full-time Quality Assurance and Regulatory Compliance Specialist to join our team.
In this role, you will create and implement Signal 1’s Quality Management System (QMS) to meet the requirements of ISO 13485:2016 (a Medical Devices Quality Standard) and the Medical Device Single Audit program (MDSAP) and assist with Signal 1’s regulatory approval applications.
Specific job responsibilities include:
- Working collaboratively with external consultants and internal technical and business teams to design a QMS that is customized to Signal 1’s products and compliant with ISO 13485:2016 standards and regulations.
- Creating and maintaining QMS documentation including quality policies, standard operating procedures, work instructions and associated records.
- Being the primary manager of record keeping and version controls, ensuring that all documents and records are correctly formatted, identified, reviewed, approved and filed.
- Being the key contact person for preparing and facilitating all necessary audits and certifications.
- Taking corrective actions when gaps are identified and continually improving the processes and procedures to ensure compliance.
- Organizing training for employees and new hires, making sure everyone is properly educated and following the procedures and processes of the QMS.
- Maintaining and updating the company’s QMS as needed over time.
- Supporting Signal 1’s regulatory approval applications.
- Supporting the creation and documentation of other internal company policies.
- Bachelor degree in a relevant field (life sciences, health sciences, software engineering). Post-graduate training in Regulatory Affairs or Quality Operations is an asset.
- Ability to work both independently and collaboratively and to take ownership over projects and effectively drive to completion.
- Exceptional organization and planning skills.
- Excellent English language written skills with keen attention to detail including ability to create, edit and proof-read technical documentation.
- Understanding of medical device quality management standards and medical device regulations including US FDA, Health Canada and ISO 13485:2016 is an asset.
- Exposure to a Quality Management System environment, preferably in the biotechnology or software sectors.
- Experience managing a project including creating plans, monitoring progress and delivering results.
- Proven ability to achieve results while working independently.
- Competitive compensation and stock options
- Entrepreneurial and energetic culture
- Excellent health and extended health coverage
- Four weeks of paid vacation
- Hybrid work model with flexibility
- Opportunity to help build impactful AI products and services that will transform hospital care
Please submit your CV to email@example.com. Thank you for your interest in Signal 1!