What are the responsibilities and job description for the Sr. Manager, Regulatory Affairs position at Accordance Search Group?
Our client, a leading global medical device company is seeking a Senior Manager Regulatory Affairs to join their division on-site in their downtown Atlanta office.
This new team member is responsible for the management and leadership of the Regulatory Affairs department. The manager is responsible for allocating and managing department resources to accomplish department and corporate objectives.
Responsibilities :
- 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 manage and coach a team of regulatory 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.
Required Qualifications
Preferred Qualifications
