Abbott Regulatory Compliance Manager in Westford, Massachusetts
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Regulatory Compliance Manager is responsible for assessing and reporting on the business unit's compliance status relative to defined quality system requirements.
Primary responsibilities include planning activities needed to assess the status of the quality system, organizing resources appropriate to execute the identified plan, approving documentation of the assessment results and corrective action taken, and reporting the status results to Management.
The Regulatory Compliance Manager also supports the quality system by taking action to align activities with Corporate Compliance objectives, by facilitating inspections with outside regulatory agencies, and by other tasks as assigned by Management.
** 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 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).
** Communicates to Management the compliance status of the business units quality system.
** Facilitates inspections of the business unit by outside Regulatory Agencies, including any required responses.
(Influence/Leadership) Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives.;
(Planning/Organization) Creates immediate to long-range plans to carry out objectives established by top management; develops and calculates a budget for a department or group to meet organizational goals; forecasts future departmental needs including human and material resources and capital expenditures; recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.
(Decision Making/Impact) Assignments are expressed in the form of objectives; makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.
Bachelor's degree and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.
** Medical Device experience is REQUIRED.
** Experience with external audits is required.
** ASQ Certification a plus
** PMP Certification a plus
(Technical/Business Knowledge (Job Skills)) 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. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.;
(Cognitive Skills) 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.
SOME INTERNATIONAL TRAVEL POSSIBLE
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org