Purpose:

The 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.  The role serves as Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer 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.                   

Responsibilities:

• Serves as the Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer under EU MDR 2017/745, supporting quality management supervision under the direction of the Management Representative.
• Hosts External Audits primarily in the US region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.
• Conducts Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
• Leads 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.
• Maintains expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
• Performs regulatory compliance assessments to support the decision-making in critical business decisions, including Market Actions.
• Analyzes & interprets quality system performance metrics, presenting to Top Management as part of Management Reviews.
• Program manages initiatives intended to improve and globalize the AbbVie quality management system.