Manager, Quality & Regulatory Affairs

MANAGER, QUALITY & REGULATORY AFFAIRS

The Quality & Regulatory Affairs Department provides strategic leadership, governance, and oversight for Integrated Medical Systems' quality systems, regulatory compliance, and continuous improvement initiatives. The department establishes the framework through which IMS ensures its biomedical services, warehouse and distribution operations, OEM partnerships, and IMED private label products consistently meet customer expectations, regulatory requirements, and organizational quality objectives.

Quality & Regulatory Affairs serves as an independent business partner committed to protecting patients, customers, employees, suppliers, OEM partners, and the IMS brand through proactive quality leadership, sound regulatory strategy, risk-based decision-making, and operational excellence.

Reporting directly to the Director of Biomedical Operations, the Manager, Quality & Regulatory Affairs provides strategic leadership for the organization's Quality Management System (QMS), Regulatory Affairs program, Supplier Quality, Biomedical Quality, Warehouse & Distribution Quality, and IMED Private Label Quality initiatives. This position is responsible for developing, implementing, governing, and continuously improving the systems, policies, and processes that support compliance with applicable regulatory requirements while enabling organizational growth, operational excellence, product commercialization, customer satisfaction, and future business expansion.

The Manager serves as the operational leader of the Quality & Regulatory Affairs Department, partnering with executive leadership and business stakeholders to establish scalable quality systems that support IMS's continued evolution as a leading provider of biomedical services, healthcare products, warehouse distribution, OEM partnerships, and private label solutions.

Job Requirements

Required 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.

Preferred Qualifications

• Master's degree preferred.
• Experience with 510(k), eSTAR, NDC administration, OTC compliance, and product commercialization.
• ASQ certifications, Regulatory Affairs Certification (RAC), ISO 13485 Lead Auditor, Lean Six Sigma, or PMP certification.

Core Competencies

• Strategic Leadership
• Regulatory Affairs
• Quality Systems
• Business Acumen
• Risk Management
• Supplier Quality
• Product Commercialization
• Executive Communication
• Operational Excellence
• Continuous Improvement
• Organizational Development

Working Relationships

This position collaborates with Executive Leadership, Biomedical Operations, Warehouse Operations, Supply Chain, Sales, Marketing, Information Technology, Human Resources, OEM partners, contract manufacturers, suppliers, customers, certification bodies, and regulatory agencies to ensure IMS quality and regulatory objectives are achieved.

Travel & Physical Requirements

• Travel up to 25% as required.
• Ability to work in office, warehouse, laboratory, and biomedical service environments.
• Ability to lift up to 30 pounds occasionally.
• Ability to travel by automobile and commercial airline.

Job Responsibilities

The Manager, Quality & Regulatory Affairs provides organizational leadership for the following business functions:

• Quality Management Systems (ISO 13485 / ISO 9001)
• Regulatory Affairs
• FDA Establishment Registration
• Medical Device Registration & Listing
• OTC Drug Compliance
• National Drug Code (NDC) Administration
• eSTAR & 510(k) Support
• Biomedical Quality
• Warehouse & Distribution Quality
• Supplier Quality
• IMED Private Label Quality
• Product Commercialization
• Risk Management
• CAPA
• Complaint Handling
• Internal Audit Program
• Management Review
• Continuous Improvement

Areas of Responsibility:

Quality Management Systems
The Manager establishes and continuously improves the IMS Quality Management System to ensure organizational compliance, operational consistency, and scalable growth.

Primary Responsibilities

• Leads the development, implementation, maintenance, and continual improvement of the IMS Quality Management System.
• Governs document control, change management, CAPA, complaint handling, internal audits, management review, quality records, and training systems.
• Establishes corporate quality objectives and performance metrics.
• Maintains organizational readiness for ISO, OEM, customer, and regulatory audits.
• Drives continuous improvement through data analysis, risk management, and cross-functional collaboration.

Regulatory Affairs
The Manager provides strategic leadership for all regulatory activities supporting IMS operations and IMED products.

Primary…