Regulatory Affairs Manager

***** Regulatory Affairs Manager***** Santa Clara, CA - 95054-2807***** 9 MonthsJob **Years ** 9+**Bachelors degree and 9+ years of related work experience or an equivalent combination of education and work experience.Advanced degree preferred.** Recruits, coaches and develops organizational talent.;Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.;Creates an entrepreneurial environment.;Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.May supervise non-exempt employees.;Keeps the organizations vision and values at the forefront of decision making and action.;Demonstrates effective change leadership.;Builds strategic partnerships to further departmental and organizational objectives.;Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.;Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).;Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.;Develops, monitors and appropriately adjusts the annual budget for department(s).; Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.;Assess proposed regulations and communicate new requirements to the organization.

Created: 2025-02-22