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Abbott · 2 hours ago

Senior Regulatory Compliance Specialist

Lake Forest, IL

Full-time

Onsite

Mid, Senior Level

$87K/yr - $173K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Regulatory Compliance Specialist will provide compliance oversight and guidance for quality systems, manage compliance activities, and facilitate inspection readiness, ensuring adherence to regulations and improvement opportunities.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Responsible for implementing and maintaining the effectiveness of the quality system

Lead projects to support Divisional scope; multi-site quality system projects with cross-functional and represent own team while on cross-functional project teams with other functional leaders

Supports achieving Division goals and strategic initiatives

Communicates confidently and effectively with management, peers and key stakeholders, ensuring successful compliance status of the Division, manufacturing sites and/or affiliates

Interprets regulations and requirements and supports implementation of program and procedures to meet requirements worldwide

Defines project goals and milestones. Responsible for timely project completion

Provide solutions to a wide range of difficult problems

Ensures solutions are compliant; innovative; thorough; practical and consistent with organizational objectives

May leads projects with cross-functional broader scope. Represents team on cross-functional projects with other functional leaders

Directly influences project direction and scope

Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly

Communicates confidently and effectively with management, peers, and key stakeholders

Contributes functional skills and expertise broadly

Scope includes one or more QA functions with general knowledge of other related disciplines

Provides guidance and trains other Professionals and Technicians

Ensures compliance to Division and Corporate policies and procedures

Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues

Qualification

Regulatory ComplianceQuality SystemsProject ManagementLife Science DegreeHealthcare Industry ExperienceCross-functional CollaborationCommunication SkillsProblem Solving