Manager Regulatory Affairs

【求人No NJB2205549】
■Role Overview
Registration and maintenance of Medical Devices

・Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of regulatory files for existing marketed products
・Identify prioritize key areas of risk and develop implement appropriate mitigation plans
・Establish appropriate communication within RA with global Marketing and with other functions at project level and favor proactive communication
・Ensure Registration strategy and deliverables are aligned with project teams and business objectives
・Lead regulatory activities related to their portfolio of products
・Prepare review and approve labeling J CTD based on global dossier and in cooperation with PV/MDS and confirm sufficiency of total submission dossier package for approval
・Represent or lead the RA function on assigned cross functional project teams
・May participate external advocacy activity and contribute internal environment improvement
・May provide direct supervision of individuals
・Monitor applicable regulatory documentation and propose solutions. Identify areas for improvement
・Develop and document sound regulatory decisions and justification