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 is an exciting opportunity to support high risk innovative products and join a high performing team to achieve global approvals.

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.
• Keep the organization's vision and values at the forefront of decision-making and action.
• 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.
• Assess proposed regulations and communicate new requirements to the organization.

Required Qualifications

• Bachelor's degree in a related field or an equivalent combination of education and experience.
• Minimum 9 years of related work experience.
• 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.
• Monitor costs of projects and of human and material resources within a department or unit.
• Monitor company-wide indicators such as market share and profitability.
• Monitor external environment in area of technical or professional responsibility.
• Develop and/or identify new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.

Preferred Qualifications

• Master's degree.
• Knowledge of submission and registration types and requirements.
• Effective verbal and written communication with diverse audiences and teams.
• Analytical thinking with good problem-solving skills.
• Experience managing and leading a team.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Ability to lead and manage multiple and competing priorities and manage programs.
• Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience with medical device software requirements and software regulations.