Senior Global Regulatory Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $125k - $150k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Creation Technologies

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

🎖️ Defense

💼 Consulting

Healthcare • Defense • Consulting

Creation Technologies is an award-winning Global Electronics Manufacturing Services provider, specializing in comprehensive solutions for Original Equipment Manufacturers (OEMs). With a strong focus on improving profitability, reducing risks, and enhancing customer satisfaction and time-to-revenue, the company offers a range of services including turnkey product design and development, lean manufacturing, test strategy and development, and after-market service solutions. Headquartered in Boston, MA, Creation Technologies has multiple manufacturing locations across the USA, Canada, Mexico, and Asia, and has maintained over 30 years of operating profitability since its establishment in 1991.

📋 Description

• Strengthen regulatory compliance and advance the Global Quality Management System across the organization • Serve as a regulatory Subject Matter Expert • Partner with sites, regional leaders, and cross-functional teams to drive consistent, effective, and scalable quality and regulatory practices • Lead and oversee QMS processes, regulatory requirements, certifications, and standards alignment • Support maintenance of regulatory compliance, record-keeping, and certifications for UL, FDA, FM, and CSA • Provide internal audit support for shared services functions and assigned sites • Manage Global Risk Management Processes as BPO • Perform customer MSA and Quality Agreement reviews • Contribute to the Company’s Vision and Strategy as a member of the Global Leadership Team • Collaborate with quality leaders and external suppliers to resolve issues and share expertise • Support key customer accounts, resolve issues, and collaborate with senior leaders • Exercise independent decision-making in technical and financial teams • Apply Lean, continuous improvement, and advanced problem-solving to manufacturing and QMS challenges • Track and manage assigned KPIs and drive quality performance improvements • Lead continuous improvement efforts to enhance site operations and customer success • Communicate across site and regional QMS, business, and customer interactions • Support cross-functional teams and foster a culture aligned with Creation Core Values • Participate in global budgeting, continuous improvement, and headcount modeling • Travel between business units, customers, and suppliers; approximately 50% travel required • Perform other duties and responsibilities as assigned

🎯 Requirements

• Bachelor’s Degree required in Quality or Technical Discipline; related discipline preferred • 7+ years relevant Quality experience in electronics manufacturing or Medical Device/Aerospace and Defense (A&D) • Minimum of 5+ years in Quality management/leadership preferred • Lead Auditor Certifications in ISO 9001, ISO 27001/27002, ISO 13485, AS9100 or equivalent experience • Proven experience leading the design, implementation, certification, and ongoing governance of an ISMS aligned with ISO 27001 and ISO 27002 • Demonstrated success establishing and governing enterprise-wide information security programs and ISO 27001/27002-compliant ISMS frameworks • Experience with information security governance, risk management, policy development, compliance oversight, and audit readiness • Experience driving organizational certification efforts, managing internal and external audits, and ensuring sustained ISO 27001 compliance • Working experience with ISO 9001, AS9100, ISO 13485/FDA, and other applicable standards • Ability to manage multiple concurrent projects and deliver results accurately and on time • Experience applying Lean Methodologies and/or Six Sigma • Advanced communication and presentation skills adaptable to various organizational levels • Highly proficient in MS Office Word and PowerPoint, with advanced knowledge in Excel • Attention to detail and organizational skills with ability to meet firm deadlines • Proven leadership in fostering collaboration, coaching, and mentoring teams • Ability to work within an ITAR regulated environment • Ideally located near a major airport; preference for candidates based in the Central Time Zone

🏖️ Benefits

• Performance-based bonuses • Range of benefits for full-time employees • Diverse, dynamic, and rewarding work environment • Opportunities to learn, work, grow, develop, and advance careers