Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The Regulatory Operations Manager will work with their group to:
1) Ensure the active, systematic collection and interpretation of data or other information about a marketed device complies with all global regulations.
2) Ensure compliance to all applicable global regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities.
3) Exceed customer expectations by responding to regulatory inquires in a professional and timely manner
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 supervise non-exempt 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 department 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 cost center(s).
Provides appropriate level of cross-functional and customer-oriented communications regarding the status of department and quality system operation, as well as product performance.
(Influence/Leadership) Establishes and cultivates an extensive network of support to facilitate completion of assignments.
Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.
May lead a project team.
Participates in determining goals and objectives for projects.
Influences middle management on technical or business solutions.
May interact with vendors.; 5. (Planning/Organization) Plans and organizes non-routine tasks w/approval.
Initiates or maintains work schedule.
Establishes priorities of work assignments.; 6. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.