Regulatory Affairs Associate III_35044

Contract: Through June 2027

Location: North Chicago, IL – Hybrid

Onsite: Tuesday, Wednesday & Thursday





K3-Innovations is seeking an experienced Regulatory Affairs Associate III to support
Process Excellence and Issue Management activities within Regulatory Affairs.

This role will help ensure Regulatory Affairs operations remain compliant, efficient, and inspection-ready while partnering with cross-functional stakeholders to manage issues, CAPAs, Exception Reports, process improvements, audits/inspections, and legacy-company integrations.





🔹 Key Responsibilities


- Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are properly logged, assessed, tracked, and resolved.
- Triage RAIM issue records by evaluating severity, impact, risk, and compliance implications.
- Escalate issues to Exception Reports when warranted.
- Project manage Exception Reports with cross-functional stakeholders to identify
root causes, corrective actions, and process improvements.
- Partner with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure effective issue management.
- Support internal and external audits and inspections, including documentation coordination, issue follow-up, and response activities.
- Manage multiple legacy company integrations into Regulatory Affairs business processes through change plans in OneTrack.
- Maintain accurate process documentation, issue records, and change plans in accordance with governance expectations.
- Support communication, implementation, and adoption of process changes across stakeholder groups.






🔹 Required Qualifications


- Bachelor's degree in Life Sciences, such as:
- Pharmacy
- Biology
- Chemistry
- Pharmacology
- Related scientific discipline
- 5+ years of regulatory, pharmaceutical, or medical device experience.
- Experience in Regulatory Affairs, Quality, Process Excellence, Business Process Management, or a related area is preferred.
- Experience managing issue/CAPA systems, Exception Reports, or comparable compliance/investigation workflows.
- Experience supporting audit and inspection readiness in a regulated environment.
- Strong organizational, analytical, communication, facilitation, and stakeholder-management skills.
- Ability to manage multiple priorities and work effectively across functions and organizational levels.
- Ability to influence without direct authority in a matrixed environment.






⭐ Preferred Qualifications


- Advanced degree in science or business.
- Relevant professional certification.
- Experience with process excellence and continuous improvement.
- Experience with regulatory issue management and CAPA processes.
- Experience managing change plans and legacy-company integrations.






👤 Ideal Candidate

The ideal candidate is a Regulatory Affairs or Quality professional with strong process-excellence and issue-management experience who can work independently while collaborating across a highly matrixed organization.

You should be comfortable assessing compliance issues, coordinating CAPA and Exception Report activities, facilitating cross-functional teams, supporting inspections, and driving process improvements without direct authority.

📩 Interested? Please reach out to learn more about this opportunity and discuss your qualifications.





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