Senior Global Regulatory Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Enhance regulatory compliance and promote the Global Quality Management System throughout the organization.

• Act as a regulatory Subject Matter Expert.

• Collaborate with sites, regional leaders, and cross-functional teams to implement consistent, effective, and scalable quality and regulatory practices.

• Lead and manage QMS processes, regulatory requirements, certifications, and standards alignment.

• Assist in maintaining regulatory compliance, record-keeping, and certifications for UL, FDA, FM, and CSA.

• Provide internal audit support for shared services functions and designated sites.

• Oversee Global Risk Management Processes in the role of BPO.

• Conduct customer MSA and Quality Agreement evaluations.

• Contribute to the Company’s Vision and Strategy as a member of the Global Leadership Team.

• Work together with quality leaders and external suppliers to address issues and share expertise.

• Support key customer accounts, resolve challenges, and collaborate with senior leaders.

• Exercise independent decision-making within technical and financial teams.

• Implement Lean, continuous improvement, and advanced problem-solving techniques to tackle manufacturing and QMS challenges.

• Monitor and manage assigned KPIs to enhance quality performance.

• Lead continuous improvement initiatives to optimize site operations and ensure customer success.

• Facilitate communication across site and regional QMS, business operations, and customer interactions.

• Assist cross-functional teams and cultivate a culture aligned with Creation Core Values.

• Engage in global budgeting, continuous improvement, and headcount modeling.

• Travel between business units, customers, and suppliers; approximately 50% travel is necessary.

• Complete other duties and responsibilities as assigned.

⛳️ Requirements

• Bachelor’s Degree required in Quality or a Technical Discipline; related field preferred.

• 7+ years of relevant Quality experience in electronics manufacturing or Medical Device/Aerospace and Defense (A&D).

• A minimum of 5+ years in Quality management/leadership preferred.

• Lead Auditor Certifications in ISO 9001, ISO 27001/27002, ISO 13485, AS9100, or equivalent experience.

• Demonstrated experience in leading the design, implementation, certification, and ongoing governance of an ISMS aligned with ISO 27001 and ISO 27002.

• Proven track record of establishing and governing enterprise-wide information security programs and ISO 27001/27002-compliant ISMS frameworks.

• Experience in information security governance, risk management, policy development, compliance oversight, and audit readiness.

• Experience in managing organizational certification efforts, conducting internal and external audits, and ensuring sustained ISO 27001 compliance.

• Familiarity with ISO 9001, AS9100, ISO 13485/FDA, and other applicable standards.

• Capacity to manage multiple concurrent projects and deliver results accurately and punctually.

• Experience in applying Lean Methodologies and/or Six Sigma.

• Strong communication and presentation skills adaptable to various organizational levels.

• Highly proficient in MS Office Word and PowerPoint, with advanced skills in Excel.

• Attention to detail and organizational abilities with a capacity to meet strict deadlines.

• Proven leadership in fostering collaboration, coaching, and mentoring teams.

• Ability to operate within an ITAR regulated environment.

• Ideally located near a major airport; preference for candidates based in the Central Time Zone.

🏝️ Benefits

• Performance-based bonuses.

• A comprehensive range of benefits for full-time employees.

• A diverse, dynamic, and rewarding work environment.

• Opportunities for learning, working, growing, developing, and advancing careers.