The Quality Senior Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members. 

Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport, otherwise in one of our other Ireland sites. 

Responsibilities:

• Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
• Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
• Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
• Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
• Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
• Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
• Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
• Program-manage initiatives intended to improve and globalize the AbbVie quality management system.