JOB DESCRIPTION :
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 97,000 people.
In Ireland, Abbott has five business units, represented across eight manufacturing sites. The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips for use in diabetes management.
Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system.
The Regulatory Affairs Manager applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs.
In collaboration with the Regulatory leadership, develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of product(s) or postmarket change management activities into global markets.
Coordinate preparation of well organized, complete, and scientifically sound regulatory submissions. Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
Exercise judgement within generally defined practices and departmental standard operating procedures. Accountable for budgets, schedules, and ensuring compliance to divisional and corporate policies as required.
Develop and maintain strong and effective relations with internal / external personnel.
Qualifications and Experience
JOB FAMILY : Regulatory Operations
DIVISION : ADC Diabetes Care
LOCATION : Ireland >
ADDITIONAL LOCATIONS : WORK SHIFT :
WORK SHIFT : Ie - Shftpre0 (Ireland)
TRAVEL : Yes, 20 % of the Time
MEDICAL SURVEILLANCE : Not Applicable
SIGNIFICANT WORK ACTIVITIES :
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Not Applicable