ABBOTT LABORATORIES SH Regulatory Affairs Project Leader; Regulatory Operations Salary in the United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

The Structural Heart Regulatory Affairs Operations Group is seeking a project leader for the Regulatory group to aide in coordinating and managing various Structural Heart Quality System activities. The role is responsible for an array of quality initiatives: from helping to develop processes and procedures, to leading various SH group quality improvement projects (including both QS to CAPA), to assisting in training initiatives, and aiding in evaluating audit findings; working cross-functionally to determine the scope, risk, business impact and resolution.  Success in this role requires skills in project management, critical thinking, problem solving, and interpersonal skills to lead cross functional teams to address compliance concerns.

General – Responsible for preparation, coordination, and deliverables associated with Regulatory Affairs’ role within the Structural Heart Quality System to include representing Regulatory Affairs in audits and establishing/refining processes to facilitate compliance in regulatory affairs activities.  Proactively leads cross-functional compliance activities across the portfolio to identify and mitigate potential risks.  Works with Quality System owners to understand process data, identify potential risks, and collaboratively develop, maintain and implement risk mitigation plans.  Seeks process solutions for compliance to regulatory intelligence inputs to ensure international regulatory requirements are assessed and compliance integrated into programs. 

Quality System Compliance – Creates, develops, and maintains adherence to the various Structural Heart Quality Policies as well as site, Division, and Corporate Quality system procedures. Stays abreast of applicable regulations and standards through training and self-driven continuous learning. Maintains awareness of business and industry compliance trends. Leads various Quality Subsystem projects involving processes such as CAPA. Will support as CAPA approver.

Risk Management - Applies basic Risk Management principles to evaluate potential compliance risks.  Develops an awareness of Division Risk Management policies and procedures and works cooperatively with stakeholders to facilitate smart processes to support nimble business compliance.

Required Experience / Skills / Education:

• Education & Experience: At least 3 years work experience in Quality / Quality Management or related field experience; Less experience may be appropriate with advanced degree.
• Skills: Receives general direction and exercises considerable discretion to own work detail.  Identifies and elevates constraints and risks and recommends possible solutions. Ensures compliant and user friendly documentation; carrying out tasks related to area of responsibility with management oversight. Decisions have short- or long-term impact. Demonstrated ability to identify and ask relevant questions. Customer-service oriented self-starter with excellent analytical, critical thinking, and creative problem-solving skills. Strong desire and ability to learn, adapt, and apply new technologies. Ability to work in a flexible and professional manner. Adept at translating business requirements into compliant solutions. Excellent oral and written communication skills including the ability to communicate effectively with both technical and non-technical stakeholders.