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.
