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.