Role: Regulatory Affairs specialist

Location: St. Paul, MN - 55117

Duration: 6 Months

Job Description:

• Years Experience: 9+
• 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.; 11. 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.