Strategic Quality & Regulatory Director

RXinsider LTD.; Bolingbrook, Northern (IL, KY); Hybrid; USD 110,000 - 135,000; Full time

Benefits offered by this job

Paid time off

401(k) with matching

Health insurance

Job summary

Integrated Medical Systems (IMS) is hiring a Manager, Quality & Regulatory Affairs to lead the organization’s Quality Management System and Regulatory program across biomedical services, warehouse distribution, OEM partnerships, and IMED private label products.

The role reports to the Director of Biomedical Operations and focuses on strategic quality leadership, risk management, audits, and continuous improvement to support scalable growth and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline.
• Five years of progressive leadership experience in regulated industries.
• Demonstrated experience with ISO 13485 Quality Management Systems.
• Working knowledge of ISO 9001, FDA regulations, supplier quality, audits, CAPA, complaint handling, and risk management.
• Experience supporting biomedical services, warehouse operations, healthcare distribution, medical devices, pharmaceuticals, or related industries.

Responsibilities

• Leads Quality Management Systems (ISO 13485 / ISO 9001).
• Oversees Regulatory Affairs, FDA Establishment Registration, Medical Device Registration & Listing, OTC Drug Compliance, and NDC administration.
• Guides Private Label & Product Commercialization quality activities.
• Manages Biomedical Quality, Warehouse & Distribution Quality, and Supplier Quality programs.
• Leads Enterprise Risk Management and strategic leadership for the Quality & Regulatory Affairs function.

Skills

Strategic Leadership

Regulatory Affairs

Quality Systems

Risk Management

Executive Communication

Operational Excellence

Continuous Improvement

Education

Bachelor's degree in Engineering, Biomedical Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline

Job description

Integrated Medical Systems (IMS) is hiring a Manager, Quality & Regulatory Affairs to lead the organization’s Quality Management System and Regulatory program across biomedical services, warehouse distribution, OEM partnerships, and IMED private label products.

The role reports to the Director of Biomedical Operations and focuses on strategic quality leadership, risk management, audits, and continuous improvement to support scalable growth and regulatory compliance.