Regulatory and Clinical Affairs Manager

We are currently seeking a Manager, Regulatory and Clinical Affairs to join our Acute Care business unit. Join us at the intersection of innovation, science, and patient care. As Manager, Regulatory and Clinical Affairs, you will play a pivotal role in shaping the regulatory and clinical strategies that enable products to reach markets globally and improve patient outcomes. You will lead a high-performing team, collaborate with cross-functional partners across the organization, and influence decisions that drive business success while ensuring compliance and patient safety. This role is Remote or Hybrid in Portage, Michigan. 

What you will do 

• Provide leadership for Regulatory Affairs and Clinical Affairs activities, establishing strategies, processes, goals, and metrics that drive measurable improvement and support business objectives. 
• Lead regulatory and clinical team members to deliver projects and activities with appropriate quality and timeliness, including oversight of priorities, timelines, deliverables, execution, and resource needs. 
• Drive integrated approaches to regulatory strategy, market access, clinical evidence generation, and the development, review, and oversight of regulatory and clinical deliverables for new and existing medical devices. 
• Manage day-to-day regulatory and clinical processes, ensuring issues are appropriately evaluated, escalated, resolved, and communicated. 
• Lead teams supporting regulatory submissions, registrations, renewals, clinical projects, and clinical evidence activities across the product lifecycle. 
• Provide direction on the interrelationship between regulatory strategy and clinical evidence, including recommendations and implementation plans for new or changing requirements and expectations. 
• Collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, Marketing, and other partners to ensure corporate goals and strategies are met. 
• Establish annual budgets and quarterly forecasts for the function and manage priorities and resources accordingly. 
• Establish and improve standard processes, systems, and controls to ensure clear ownership, effective management, and continuous improvement of regulatory and clinical activities. 
• Chair meetings needed to drive closure of regulatory and clinical issues and decisions. 
• Manage and provide updates on regulatory and clinical metrics, trends, risks, and performance. 
• Represent regulatory and clinical processes during internal and external audits and inspections. 
• Define targets, KPIs, and performance objectives for individuals within the function and manage direct reports to meet or exceed expectations. 
• Recruit, select, and onboard top talent; coach and develop team members; address performance issues; and maintain a high level of team engagement. 
• Participate in advocacy and other activities of an advanced technical, tactical, audit, or strategic nature. 

What you need 

• Bachelor's degree in science, engineering, life sciences, biology, biomedical engineering, nursing, or a related discipline required; advanced or master's degree preferred. 
• Minimum of 8 years of relevant experience including regulatory affairs and/or clinical affairs experience in the medical device industry. 
• Minimum of 2 years of management experience required, and/or demonstrated high-performance leading critical projects or teams. 
• Demonstrated ability to apply regulatory and clinical knowledge to cross-functional and interdivisional projects. 

Preferred 

• Experience planning or conducting clinical studies, including Investigational Device Exemption (IDE) and post-marketing clinical studies, strongly preferred.
• Demonstrated ability to integrate regulatory strategy and clinical evidence needs to support product development, submissions, market access, and lifecycle activities. 
• Strong written, verbal, listening, communication, team building, and stakeholder-management skills. 
• Demonstrated ability to collaborate effectively with and lead cross-functional teams and external stakeholders. 
• Demonstrated ability to prioritize and manage multiple project workloads. 
• Demonstrated experience with trending, analysis, metrics, and reporting. 
• Demonstrated leadership, decision-making, process-improvement, and change-management skills. 
• Experience with recruiting, onboarding, coaching, and people development. 
• Ability to influence across the organization and communicate recommendations to management and cross-functional stakeholders.