Trouvez votre prochaine possibilité

Détails du poste

Company Description Traferox creates, manufactures and commercializes products used for preservation, perfusion and assessment of solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox Technologies is committed to improving the outcomes of organ transplants and to saving patients’ lives. Location: The work will be performed in the company’s place of work at 2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5. Minimal travel (< 10%) is expected. Traferox Technologies Inc. Job Description Union: Non-Union Number of Vacancies: 1 New or Replacement Position: New Site: 2400 Skymark Avenue, Mississauga Department: Quality and Regulatory Reports to: Regulatory Affairs Manager Salary Range: $85,000 - $115,000 annually Hours: 37.5 Hours Per Week Shifts: Days, Monday - Friday Status: Permanent Full-time Closing Date: Open until filled Duties and Responsibilities: Prepare technical documents to support market-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents. Maintain regulatory files for EU, US, Canada, and other regulated markets, ensuring that files are updated to reflect current products and standards. Maintain company facility and product licenses and registrations in all active jurisdictions including renewals, device listings, site registrations, supplements for changes and annual reports. Prepare responses to regulatory authorities’ questions within assigned timelines. Stay abreast of updates to regulations and standards. Perform gap analyses and make required changes in Traferox procedures as required. Maintain procedures in compliance with ISO 13485 and MDSAP requirements. Assess device related complaints for medical device reporting requirements. Prepare country-specific forms for reportable incidents within the required timeline. Lead any required regulatory notices, recalls and field actions. Maintain product UDI listings in country-specific databases. Participate in internal and external audits, providing regulatory input as needed. Coordinate writing and executing corrective action plans for audit nonconformances related to regulatory functions and documents. Assess and document regulatory impact of product design changes in jurisdictions where product is licensed. Oversee post-market surveillance activities for licensed products. Qualifications Bachelor of Science Degree (or equivalent) Post-Graduate Degree or Certificate in Regulatory Affairs, or equivalent work experience 7+ years’ experience in medical device or biologics regulatory affairs Experience authoring original device submissions in US, Canada, or EU Familiarity with medical device standards and regulations such as ISO 13485, ISO 14971, EU MDR, US FDA 21CFR, Canada SOR 98/282 Excellent written and verbal skills Excellent organization and file management skills Proficient with Microsoft office products Adaptable, able to work both independently and with high performance teams Ability to consume and understand technical and clinical information to support regulatory filings and summaries Exposure to complaint handling and adverse event reporting Additional Information We thank all applicants for their interest in this position with Traferox Technologies Inc. Please note that only candidates selected for an interview will be contacted. Compensation: CAD 85000 - CAD 115000 - yearly

Ce que vous ferez

The specialist will prepare technical documentation for regulatory submissions and maintain compliance with international standards across various markets. They will also oversee post-market surveillance, manage product licenses, and coordinate responses to regulatory authorities.

Exigences

Candidates must hold a Bachelor of Science degree and a post-graduate qualification in Regulatory Affairs, or equivalent experience. A minimum of 7 years of experience in medical device or biologics regulatory affairs is required, along with proficiency in relevant global standards.

Compétences indiquées

• Microsoft Office · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Regulatory affairs
• Medical device regulations
• Technical documentation
• ISO 13485
• MDSAP
• EU MDR
• US FDA 21CFR
• Canada SOR 98/282
• Post-market surveillance
• Complaint handling
• Adverse event reporting
• Regulatory submissions
• Audit support
• Gap analysis
• Microsoft Office
• Regulatory Affairs
• Medical Devices
• Title 21 Of The Code Of Federal Regulations
• Auditing
• Biopharmaceuticals
• Hospital Information Systems
• External Auditing
• File Management
• Hepatology
• Internal Auditing
• ISO 14971 Standard
• ISO 13485 Standard
• Kidneys
• Perfusion
• Product Design
• Regulatory Filings
• Medical Device Reporting
• Pancreas

Domaines d’emploi

• Healthcare
• Science & Research
• Manufacturing
• Engineering
• Regulatory Affairs Specialist
• Legal Professionals Not Elsewhere Classified
• Regulatory Affairs Specialists
• Compliance Officers