The Senior Regulatory Affairs Specialist is responsible for: assisting with the preparation of regulatory submissions in order to obtain and maintain the necessary regulatory approvals/clearances/licenses, providing regulatory support to cross-functional initiatives as required, and directing the work of less experienced regulatory staff to extend and develop their skills for the successful global registration and commercialization of Sirtex products.PRIMARY RESPONSIBILITIES:Prepare and file regulatory submissions with minimal supervision, for countries that have complex requirements such as US FDA (e.g., 510(k), PMA, etc.), Australia, Canada, China and other international markets.Prepare product information changes as required by relevant regulatory bodies.Lead or compile all materials required in license renewals and annual registrations. Drive timely registration of products in compliance with applicable regulations and guidance.Conduct regulatory assessment on design, manufacturing, labeling and other product information changes and recommend action.Review procedures for compliance to regulatory requirements as well as support updates to other Quality system procedures as required.Assist with the review of advertising information or publications communicated from the company to satisfy regulatory and corporate compliance requirements.Analyze the technical content of new registration packages to ensure they comply with country regulations prior to submission.Assist with the review of new clinical trial protocols to ensure regulatory requirements and future regulatory needs are metLiaise with industry associates and regulatory bodies as requiredReview events to determine complaint and reportability status. Support or lead, as assigned, any regulatory reporting required by Regulatory Agencies.Support post-market regulatory compliance activities.Participate in regulatory inspections/audits as required.Participate in product risk analyses as required.Provide regulatory support to internal project teams and other departments as necessary. 
