Cache of job #13929799

Job Title

Regulatory Affairs Specialist

Employer

Abbott

Location

Donegal

Description

Abbott Diabetes Care. 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 Free0053tyle Libre system. Senior Regulatory Affairs Specialist. The Regulatory Affairs Specialist applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs. Responsibilities. Works with Regulatory leadership to develop and implement regulatory strategies for product introductions and modifications per agreed schedule. Maintains strong communication and working relationships with all departments across division sites, Third Party Manufacturers, suppliers, and external personnel. Ensures that appropriate documentation is maintained to record regulatory decisions and verification/validation evidence in support of change control activities related to product design or manufacture. Maintain a high level of technical understanding with all new products. Provides strategic regulatory input (including all feasible alternatives and associated risks) and drives cross-functional alignment with issues that could have regulatory ramifications. Maintains the effectiveness of the Quality System at the site in accordance with divisional and corporate requirements and applicable regulations. Manages the preparation of registration documents as required for international markets. Provides input and comment on regulations and standards which may affect division products. Accountable for cross-functional project communication. Accountable for budgets and schedule. Qualifications & Experience. The selected candidate will have a minimum of 5 years’ experience working in ISO 13485 medical device industry either supporting product launch / product iterations and change management activities. They will also have a third level qualification in a related discipline. This job originally appeared on RecruitIreland.com.

Date Added

2052 days ago

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