REMOTE Job

What You’ll Do:

• Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements.
• Identifies, analyzes and implements country specific requirements necessary for product related submissions.
• Recommend strategies for earliest possible approvals for marketing applications.
• Performs regulatory projects or acts as a member of the project steering group.
• Submits required documentation/information to local authorities or Varian internal.
• Initiates and escalates necessary activities if deviations are identified.
• Ensures creation of adequate documentation for audits/inspections.
• Performs training within the organization in country specific regulatory requirements, if applicable.
• Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.
• Performs review of promotional material for regulatory compliance according to country specific requirements.

What You Bring:

• 5-8 years’ experience.
• Product Registration Experience:

• Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files.
• Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
• Knowledge of regulatory guidance documents (FDA, Health Canada, and EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
• Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1 as evidenced by coursework or submissions that required use of each standard.