Manager Regulatory Affairs
Abbott AG
Donegal Town, Ireland
9d ago

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.

Main 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 schedules
  • Qualifications and Experience

  • Bachelors Degree in a related subject with a min of 6 year's experience ideally in the medical device industry
  • 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

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