Senior Regulatory Affairs Specialist at University… · Mississau…

companyDescription
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.
jobDescription
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
additionalInformation
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.