Senior Manager of Regulatory Affairs & Design Assurance

A medical device manufacturing client is looking to hire a Senior Manager of Regulatory Affairs and Design Assurance in the Twin Cities. This person will lead regulatory and design assurance teams in support of enterprise objectives, establish the organizational roadmap and operating strategy, and ensure regulatory, quality, and design assurance requirements are clearly defined and effectively implemented across the organization. What You’ll Do Lead a regulatory and design assurance team of five people while being responsible for departmental resources, budgets, organizational planning, and strategic priorities. Partner with executive and quality leadership to establish organizational strategy, operating models, governance processes, and continuous improvement initiatives. Ensure products, processes, and operations comply with applicable regulatory and quality requirements, including FDA regulations, ISO 13485, EU MDR, and relevant international standards. Develop and implement regulatory, design quality, and product development strategies using risk-based and business-focused approaches. Provide leadership and oversight for regulatory affairs, commercial regulatory activities, and outsourced clinical affairs. Direct design assurance activities across the product lifecycle, including verification and validation, design inputs, quality and safety testing, certification, standards management, risk management, FMEA, human factors engineering, reliability engineering, and Design History File management. Translate customer needs and clinical-use environments into appropriate design inputs and quality requirements. Establish and maintain effective design assurance and product development practices that support innovation while maintaining regulatory and quality compliance. Build, develop, and retain a high-performing regulatory and design assurance team. Manage international product registration activities, including submission planning, maintenance of registration dossiers, and development of long-term international regulatory strategies. Lead regulatory and quality remediation initiatives when required. Provide regulatory and design assurance leadership on cross-functional product development and business project teams. Establish quality strategies for new product development, including identification of applicable standards, design verification requirements, and human factors considerations. Develop and maintain strategic relationships with contract research organizations, testing laboratories, certification organizations, and other external service providers. Lead and coordinate regulatory inspections and external audits, including interactions with government agencies and third-party certification bodies. What We Are Looking For Bachelor's degree in science, engineering, or a related technical discipline. 5+ years of progressively responsible experience in regulatory affairs, quality, design assurance, compliance, or a related discipline within the life sciences or another highly regulated industry. 2+ years of people-management or organizational leadership experience within a regulated industry. Demonstrated success leading regulatory, quality, design assurance, and/or compliance functions while supporting broader business objectives. Strong working knowledge of medical device regulations and quality systems, including FDA requirements, ISO 13485, EU MDR/MDD, and applicable international standards. Strong written and verbal communication skills, including the ability to effectively interact with regulatory agencies, notified bodies, auditors, and certification organizations. Ability to interpret and resolve differences involving regulations, standards, quality systems, and design assurance requirements. Proven experience developing, implementing, and executing regulatory, quality, and compliance strategies. Strong understanding of risk-based approaches to product development and regulatory compliance. Ability to collaborate effectively with executive leadership, cross-functional teams, and external partners. Experience leading organizational change, continuous improvement, and the development of high-performing technical teams. #J-18808-Ljbffr Cypress HCM