Regulatory Affairs Document Coordinator

Job Title: Regulatory Affairs Document Coordinator

Location: 675 North Field Drive Lake Forest IL 6004

Position Overview:

• seeking a Regulatory Affairs Document Coordinator to join our team. In this role, you will be responsible for supporting the Regulatory Affairs organization by leading document quality activities and ensuring regulatory compliance. You will collaborate across functions to develop, review, and manage regulatory documentation to meet project timelines and business objectives.

Key Responsibilities:

• Develop and maintain document templates and procedures for IVDR (In Vitro Diagnostic Regulation) performance evaluation documents.
• Review and edit quality system documents to ensure accuracy, clarity, and regulatory compliance.
• Collaborate with cross-functional teams to ensure documentation meets procedural and regulatory requirements.
• Lead and drive cross-functional team activities to complete document approvals within project timelines.
• Deliver solutions that are compliant, practical, and aligned with Abbott’s quality and regulatory standards.
• Ensure adherence to the Quality System, including addressing non-compliance issues and maintaining key processes.

Qualifications:

Required:

• Apprenticeship or Bachelor’s degree in Life Sciences, Engineering, or a related discipline OR an equivalent combination of education and experience.
• Minimum of 5 years of experience in Regulatory Affairs, Quality, or a related field (advanced degree may offset experience requirement).
• Experience within the healthcare industry preferred.

Job Type: Full-time

Pay: $70.00 - $72.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person

Salary : $70 - $72