The Director of Clinical Affairs and Operations will be responsible for the implementation and administration of all clinical activities related to domestic and/or international clinical studies to assure conformance to regulatory and company objectives. This includes coordination and execution of all operational aspects of clinical studies. They will also be responsible for preclinical studies in support of clinical goals. 

Responsibilities: 

• Develop preclinical and clinical study objectives, strategy, scope and schedule to meet company objectives. 
• Research and develop appropriate study materials, including protocols, consent materials and case report forms, to support both preclinical and clinical investigations. 
• Conduct all preclinical and clinical studies according to: 
• The protocol and associated materials 
  
• The local regulatory body  
• The local regulations 
• The competent authority 
• The governing laws and guidelines 
• Perform/oversee study site qualification/initiation and monitoring activities. 
• Train clinical sites to study protocol, complete case report forms and Adverse Event (AE) reports and maintain good clinical practices. 
• Oversee management of study data, including accuracy of data collection, CRF audit with source documents and queries, data entry, and analyses. 
• Assist investigators in generating written reports of clinical results for regulatory agencies or scientific meetings.  
• Disseminate clinical results to others in the company. 
• Participate in design reviews of new products. 
• Develop study budgets (staff and study related), including assisting with study compensation and reimbursement payments. 
• Negotiate clinical trial agreements, clinical service agreements and agreements for preclinical study activities. 
• Manage domestic and international clinical personnel. 
• Obtain clinical feedback from external expert consultants to support new clinical product development. 
• Develop standard operating procedures for Clinical Affairs. 
• Procure clinical supplies. 
• Report to CEO, COO and CMO on the clinical progress of the company. 
• Comply with ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. 
• Comply with ISO 13485, EU Medical Device Regulations, FDA 21 CFR, Part 820, Quality System Regulation, and MDSAP concerning Quality Management System for medical devices. 
• Mentor/supervise domestic and international clinical personnel to ensure compliance with regulations and company objectives and support advancement.  
• Coordinate and nurture working relationships with external expert consultants to obtain clinical feedback and expert medical opinions for clinical applications. 

Qualifications:  

• BS minimum or an MS in a scientific discipline, such as medical/scientific field, biological science, RN or similar, or equivalent experience.  
• 10+ years of clinical research experience and management in a Class II or III medical device setting. Sound knowledge of good clinical practice (GCP) with good written and verbal communication skills. Familiarity working in a hospital environment and collaborating with physicians/nurses in a clinical environment. Experience working with the FDA through the entire IDE process.  

Skills:  

• Strong knowledge of good clinical practice (GCP) and regulatory compliance guidelines. 
• Proficient in running multi-site clinical studies (domestic and international) and clinical research design.  
• Ability to grasp technical issues and concepts as well as strong organizational skills.  
• Proficient with computer skills. 

Workplace type: Remote/Hybrid. The work environment may be in the office or off site where clinical studies are conducted. Work will involve domestic and international travel up to 40%. 

Job location: Toronto, Ontario, Canada  

Job type: Full-time 

The Product Development Engineer will report to the CIO. They will be responsible for product development using design controls and project management. The Product Development Engineer will oversee and manage supplier and contract manufacturer activities.  

Responsibilities:  

• Develop medical device for market release. 
• Investigate and evaluate existing technology. 

• Design and implement new methodologies, materials, machines, processes, or products to bring concepts to market, including essential product and process documentation. 
• Source and identify suppliers and components for incorporation into devices. 
• Conduct feasibility studies of the design to determine ability to function as intended. 
• Maintain detailed documentation throughout all phases of research and development. 
• Work with mechanical designers to create new designs with proper documentation. 

• Provide technical support to production/contract manufacturing partners, including inspection activities, as needed. 
• Generate product or process qualification protocols and test reports for product design verification and validation testing and conduct product or process qualification testing. 
• Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines. 
• Investigate product failures, non-conformances, and complaints, as needed.  
• Perform purchasing activities, as needed.  

• Comply with ISO 13485, EU Medical Device Regulations, FDA 21 CFR, Part 820, Quality System Regulation, and MDSAP concerning Quality Management System for medical devices. 

Qualifications:  

• Minimum bachelor’s degree in mechanical or biomedical engineering. 
• Minimum 5 years in medical device product design and development.  

Skills:  

• Familiarity with ISO 13485, MDR, and FDA Quality System Regulation.  
• Demonstrated ability to bring a product from concept to market and to interact with client companies professionally.  
• Proficiency in Solid Works and 3D CAD.  
• Understanding and experience with fluid path, software development, optical, and high voltage electrical design.  
• Knowledge of probability, statistics, and basic physiology along with knowledge in one or more technical areas, such as thermodynamics.  

• Project management, leadership, communication and presentation skills are a plus. 

Workplace type: Remote/Hybrid 

Job location: Toronto, Ontario, Canada  

Job type: Full-time 

This position is an onsite full-time opportunity. The Senior Program Manager will report to the CEO.  

Responsibilities: 

• Move strategic opportunities forward in a timely manner 
• Identify planning conflicts 

• Define releases with R&D  
• Manage product roadmap and timelines  
• Ensure adherence to the budget and deliver early deviation warning 
• Coordinate and drive accountability with cross-functional teams including R&D, Operations, Regulatory, Clinical, Quality and Commercial activities  
• Report project status and progress to senior management  

• Lead project management, planning and support for the SpinaFX team in the development of the medical device for market release. 
• Formulate, harmonize and consolidate project scopes, plans, strategies, and budgets for projects, working closely with all cross-functional teams. 
• Lead project planning, scheduling, monitoring, and reporting of projects. 
• Ensure division-wide collaboration, realistic planning, and problem-solving are incorporated into project execution. 
• Drive for resolution in cross-functional problem solving, communication, and integration. 

• Liaise with other project owners, functional managers, and management to prioritize activities across programs to monitor business processes and balance resource availability, program deliverables and schedule, and business needs. 
• Execute programs to completion and assure successful market entry or make a timely recommendation to management to terminate a program if required by technical, commercial, or other developments that may result in project failure if not resolved through creative problem solving. 
• Identify areas for process improvement and define and implement solutions, liaising with other stakeholders such as project owners, functional managers, and senior management as appropriate. 
• Ensure that cross-functional members work as a team by focusing on business goals and managing program and solution interdependencies. 
• Quickly adapt and produce in a rapidly changing environment, meeting aggressive product launch schedules. 

• Actively champion PMO best practices to drive better project planning, execution, project prioritization and change management within commercial programs. 
• Conduct program review meetings with affiliates and provide regular updates. 
• Support product rollouts and geography expansion projects. 
• Establish and monitor KPIs to assess delivery performance. 
• Support and participate in quality management and quality systems development and management activities 

• Ensure integrity, accuracy, clarity, professionalism and visual appeal of all the produced documentation.  

Qualifications:  

• Minimum bachelor’s degree in a discipline appropriate to the project or an equivalent combination of education and work experience.  
• PMP Certification 
• Bachelor of engineering not required, but highly relevant. 

• Minimum 10 years of related work experience.  
• Medical device industry and ISO13485/MDSAP environment experience is a plus, but not required. 

Skills:  

• Experience leading several high-complexity projects from beginning to end.  
• Demonstrated technical skills and management judgment appropriate to the project. Demonstrated expertise in PM tools and processes.  

• Project management, leadership, communication, and presentation skills a plus.  

Workplace type: On-site 

Job location: Toronto, Ontario, Canada  

Job type: Full-time 

The Quality & Regulatory Director will report to the Chief Operating Officer. The Quality & Regulatory Director will be responsible for the creation, implementation, and maintenance of the quality management system and regulatory compliance, including correspondence with regulatory bodies. They will act as the management representative reporting to the management team on performance for quality improvements. They will oversee regulatory affairs in the submission of clinical investigations and pre-market approval applications to various global health ministries and regulatory bodies. 

Responsibilities: 

• Establish and maintain policies and procedures to ensure compliance with ISO 13485 – QMS for Medical Device, FDA 21 CFR, Part 820, Quality System Regulation, and MDSAP. 
• Conduct ongoing quality training. 

• Manage and perform document control activities. 
• Analyze manufacturing and inspection data for quality improvement and cost reductions. 
• Oversee and maintain the corrective and preventive action system. 
• Oversee and maintain the internal audit system. 
• Oversee the administration and disposition for nonconforming materials. 

• Manage supplier qualification activities, perform supplier onsite audits and monitor supplier performance. 
• Establish and maintain systems for monitoring and tracking supplier performance. 
• Establish and maintain systems for trending and tracking. 
• Perform management reviews, advise management of any product-related issues and make recommendations for improvement. 
• Administrate the supplier quality program by initiating the supplier evaluation process for new suppliers, sending Supplier Corrective Action Request (SCAR), monitoring and tracking their receipt, and generating and distributing supplier performance reports. 

• Plan and manage internal audit activities. 
• Compose, review, and maintain CE Technical Files. 
• Compose, review, and file FDA submissions.  
• Interface with all QA/RA audit bodies and manage and support the corrective actions of observations made during such audits.  
• Manage and perform vigilance and medical device reporting. 

• Support engineering, design input requirements and manufacturing projects, as needed.  
• Provide signatory approvals for quality and regulatory affairs, where applicable. 
• Supervise document control, quality assurance, and quality control personnel  
• Oversee/supervise the work of QA/RA consultants  

Qualifications:  

• Must have a Bachelor of Science or equivalent work experience. 
• Minimum 10 years of related work experience.  
• A minimum of 5 years in a quality system management position. Minimum 5 years of medical device experience. Strong working knowledge of ISO 13485, EU Medical Device Regulations, and FDA 21 CFR, Part 820, Quality System Regulation. 

Skills:  

• In-depth knowledge of ISO 13485, MDR and FDA quality system regulation and strong quality management knowledge.  

• Must have excellent verbal and written communication skills. 

Workplace type: Remote/Hybrid 

Job location: Toronto, Ontario, Canada  

Job type: Full-time