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 Responsibilities Oversees FDA Establishment Registration, Medical Device Listings, OTC Drug Listings, and National Drug Code administration. Supports regulatory pathways including eSTAR and 510(k) submissions. Reviews product labeling, Instructions for Use (IFUs), packaging, and product claims. Serves as the primary liaison with regulatory agencies, OEM partners, certification bodies, and regulatory consultants. Evaluates regulatory changes and ensures organizational compliance. Private Label & Product Commercialization The Manager provides quality and regulatory leadership supporting IMS and IMED branded products throughout their lifecycle. Primary Responsibilities Oversees quality planning for new product introductions. Leads quality activities supporting product commercialization. Establishes Quality Agreements with contract manufacturers. Reviews packaging validation, artwork approvals, incoming inspection, product traceability, and lot release. Supports product lifecycle quality management. Biomedical Quality The Manager establishes quality systems supporting biomedical depot and field service operations. Primary Responsibilities Provides quality oversight for preventive maintenance and repair programs. Oversees technician competency, calibration systems, and service validation. Supports implementation of new OEM service partnerships. Conducts quality audits supporting operational consistency and customer satisfaction. Warehouse & Distribution Quality The Manager develops quality systems supporting warehouse operations and product distribution. Primary Responsibilities Oversees receiving inspection, quarantine, environmental controls, storage requirements, inventory traceability, returned goods processing, and product disposition. Partners with Warehouse Operations to improve inventory accuracy and distribution quality. Supports warehouse expansion through scalable quality processes. Supplier Quality Primary Responsibilities Develops supplier qualification and monitoring programs. Oversees supplier audits, Supplier Corrective Action Requests (SCARs), supplier quality agreements, and supplier risk management. Partners with Supply Chain to strengthen supplier performance. Enterprise Risk Management Primary Responsibilities Leads quality risk management activities utilizing ISO 14971 principles where applicable. Evaluates organizational quality and regulatory risks. Reviews complaint trends, CAPA effectiveness, supplier performance, and audit findings. Promotes risk-based decision-making throughout the organization. Strategic Leadership The Manager serves as the organizational leader responsible for advancing the Quality & Regulatory Affairs function in alignment with IMS's strategic vision. Primary Responsibilities Develops annual departmental goals and strategic initiatives. Advises executive leadership regarding quality, regulatory, and operational risk. Supports expansion of OEM partnerships, IMED private label products, warehouse operations, and future manufacturing initiatives. Represents IMS during customer, OEM, supplier, ISO, and regulatory interactions. Promotes a culture of accountability, compliance, operational excellence, and continuous improvement. Leadership Expectations The Manager, Quality & Regulatory Affairs is expected to: Lead with integrity, accountability, and professionalism. Build collaborative relationships across all departments. Develop future quality professionals. Balance compliance with operational efficiency. Drive continuous improvement throughout the organization. Serve as a trusted advisor to executive leadership. Decision-Making Authority The Manager has authority to: Approve quality documentation and controlled documents. Approve CAPA plans and effectiveness verification. Approve supplier qualifications and Quality Agreements. Recommend product holds, quarantines, field actions, and recalls. Escalate quality and regulatory concerns directly to executive leadership. Job Benefits Paid time off 401(k) w/ matching Dental insurance Health insurance with 100% of premiums covered by IMS employees Vision insurance Employee Wellness Program through Revive Health The Manager, Quality & Regulatory Affairs serves as the strategic leader responsible for protecting the integrity of IMS products, services, and business processes while enabling innovation, regulatory compliance, operational excellence, and sustainable growth. Through collaborative leadership, sound judgment, and a commitment to continuous improvement, this position establishes the quality framework that supports the organization's continued success and reinforces IMS's commitment to its customers, OEM partners, employees, and the patients ultimately served. Salary 110000 - 135000 USD (yearly) #J-18808-Ljbffr RXinsider LTD.