Job Description

Role: Regulatory Affairs Manager

Location: Santa Clara, CA - 95054-2807

Duration: 9 Months

Job Description:

Years Experience: 9+

Education:

Bachelor's degree and 9+ years of related work experience or an equivalent combination of education and work experience.

Advanced degree preferred.

Duties:

• 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 organization's 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.

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