Senior Regulatory Affairs Specialist

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.
• 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

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.