Job Description
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
- Bachelor’s Degree in a related field or an equivalent combination of education and experience
- Minimum 9 years related work experience.
- Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
- Monitors costs of projects and of human and material resources within a department or unit.
- Monitors company-wide indicators such as market share and profitability.
- Monitors external environment in area of technical or professional responsibility.
- Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
- Facilitates others' participation in the continuous improvement program.
- Investigates and solves problems that impact work processes and personnel within or across units or departments.
- Develops and communicates a vision for the organizational unit assigned.
Preferred Qualifications
- Master’s degree
- Submission / registration types and requirements
- Experience working with Class III implantable devices.
- Effective verbal and written communication with diverse audience and team.
- 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).
- Must be able 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.
- Ability to identify risk areas and escalate issues as appropriate.
- Relocation assistance available.
Job Tags
Work experience placement, Relocation package,