Senior Manager, Medical Device Quality Systems

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

The Sr. Manager, Medical Device Quality Systems, is responsible for supporting 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 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 under EU MDR 2017/745, supporting quality management supervision under the direction of the Management Representative.
• Hosts External Audits, 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