Senior Manager Regulatory Affairs

Title: Senior Manager Regulatory Affairs

A leading global Medical Device company is seeking a Senior Manager of Regulatory Affairs to join their team on-site in their downtown Atlanta office. This new team member will be responsible for the management and leadership of the Regulatory Affairs department, allocating and managing department resources to accomplish both departmental and corporate objectives.

What You'll Work On

• Recruit, coach, and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Create an entrepreneurial environment.
• Provide direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• Manage and coach a team of regulatory employees.
• Demonstrate effective change leadership.
• Build strategic partnerships to further departmental and organizational objectives.
• Develop and execute organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitor compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.).
• Make decisions regarding work processes or operational plans and schedules to achieve departmental objectives.
• Develop, monitor, and appropriately adjust the annual budget for department(s).
• Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.

Required Qualifications

• Bachelor's degree in a related field or an equivalent combination of education and experience.
• Minimum 9 years of related work experience.
• MUST have hands-on experience authoring PMA submissions
• Experience working with Class III implantable devices.
• Provide direction and monitor progress of exempt specialists and/or supervisory staff toward departmental goals.