Manager of Compliance

You will oversee the full lifecycle of quality and regulatory compliance activities, ensuring adherence to applicable medical device regulations and internal quality standards while embedding Lean-Agile principles into the quality management system. You will lead cross-functional collaboration and continuous improvement efforts to strengthen operational and regulatory performance. Key responsibilities include:

• Leading the planning, execution, and monitoring of compliance and quality activities across the organization
• Managing and developing a compliance team, including performance management, coaching, and capability building
• Serving as the primary subject matter expert for quality and regulatory matters across Agile product teams and leadership
• Partnering with engineering, product, and release management teams to align compliance with development lifecycle processes
• Driving risk identification, assessment, and mitigation strategies related to product quality and regulatory readiness
• Overseeing internal audit programs and coordinating external regulatory inspections and audits
• Managing regulatory operations including documentation control, labeling updates, UDI requirements, and reporting obligations
• Establishing quality metrics, monitoring performance trends, and driving continuous improvement initiatives

Requirements

This role requires strong expertise in regulated software environments, particularly within medical device quality systems, combined with leadership experience in Agile-driven organizations. You should bring both technical regulatory knowledge and the ability to translate complex requirements into practical guidance for cross-functional teams. Key qualifications include:

• Bachelor’s degree in science, information systems, business, or a related field
• 5+ years of experience in quality assurance and/or regulatory affairs within FDA-regulated or medical device environments
• Strong knowledge of FDA quality system regulations and ISO 13485 standards
• Familiarity with ISO 14971 risk management and IEC 62304 software lifecycle standards
• Experience working with Agile software development teams and release processes
• Proven ability to lead teams, manage priorities, and drive organizational compliance initiatives
• Strong communication skills with the ability to simplify technical regulatory concepts for diverse audiences
• Experience conducting or supporting internal and external audits, including regulatory inspections
• Certifications such as ASQ CQA, CMQ/OE, or SAFe Agile are considered a plus
• Ability to travel up to 20% as needed

Benefits

• Competitive salary ranging from 104,934 to 164,897 USD, depending on experience and location
• Flexible work arrangements and remote-friendly environment
• Opportunity to work in a highly impactful, regulated healthcare technology space
• Professional development and certification support
• Exposure to modern Agile and Lean product development practices
• Collaborative and mission-driven work culture
• Travel opportunities for audits, inspections, and team collaboration