Description :

• 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 Client / 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.

Impacts :

Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.

Education :

Bachelors degree in sciences, pharmacy, medicine, nursing, dentistry, law, business, or related areas with 5 years the experience below;

or Master's degree in Regulatory affairs with 2 years of the experience below.

Required 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, 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, ISO 10993-1 as evidenced by coursework or submissions that required use of each standard
• Teamwork and collaboration : Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
• Experience with Business Tools : Proficient in utilizing business tools such as : E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.
2 days ago