Regulatory Affairs Associate Iii Regulatory Process Excellence Capa Management Inspection Readiness

Regulatory Affairs Associate III - Regulatory Process Excellence, CAPA Management & Inspection Readiness Location: Hybrid – North Chicago, IL (onsite Tuesday, Wednesday, and Thursday) Length of Assignment: Through June 2027 Pay Rate: $60-63/hr (depending on candidate medical benefits preference) Job Description: The Manager, Process Excellence within Regulatory Affairs is responsible for managing key process excellence and issue-management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness, audit and inspection response activities, and the management of change plans for legacy company integrations into Regulatory Affairs business processes. Key Responsibilities: Manage the Regulatory Affairs Issue and CAPA Management system (RAIM), ensuring issues are appropriately logged, assessed, tracked, and resolved. Triage RAIM issue records to determine severity, impact, and appropriate next steps. Escalate issue records to Exception Reports when warranted based on risk, compliance impact, or process significance. Project-manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve processes. Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue-management activities are timely, coordinated, and effective. Provide support during internal and external audits and inspections, including documentation coordination, issue follow-up, and response support as needed. Manage multiple legacy-company integrations into Regulatory Affairs business processes through change plans in OneTrack. Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations. Partner with stakeholders to support the effective communication, implementation, and adoption of process changes. Qualifications: Bachelor’s degree in life sciences, such as pharmacy, biology, chemistry, pharmacology, or a related discipline. Relevant advanced degree in science or business is preferred. Relevant professional certification is a plus. Minimum of five years of experience within the pharmaceutical, medical-device, or regulatory industry. Experience in Regulatory Affairs, Quality, process excellence, business-process management, or a related function is preferred. Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows. Experience supporting audit and inspection readiness within a regulated environment. Strong organizational, analytical, communication, facilitation, and stakeholder-management skills. Ability to manage multiple priorities and collaborate effectively across functions and organizational levels. Ability to influence without direct authority and work successfully in a matrixed environment. People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.