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Creation Technologies is seeking an experienced Senior Global Regulatory Manager to play a key role in strengthening regulatory compliance and advancing our Global Quality Management System across our organization. Reporting directly to the Senior Director of Global Quality, this highly visible position will serve as a regulatory Subject Matter Expert, partnering with sites, regional leaders, and cross functional teams to drive consistent, effective, and scalable quality and regulatory practices. The role will provide leadership across areas such as ISO 9001, ISO 13485, AS9100, ISO 27001/27002, global auditing, risk management, regulatory governance, customer requirements, quality agreements, KPI verification, and QMS optimization.
This is an exciting opportunity for a regulatory and quality professional who enjoys operating at both the strategic and hands on levels. The Global Regulatory Manager will help lead global quality initiatives, support internal and external customers, strengthen compliance, reduce Cost of Poor Quality, and continuously improve QMS processes across Creation's global footprint. The ideal candidate brings strong technical knowledge, project management capabilities, and the ability to influence and collaborate across a complex international organization. Travel of approximately 50% is required, so candidates should ideally be located near a major airport, with a preference for those based in the Central Time Zone. Candidates must also be able to work within an ITAR regulated environment.
DUTIES AND RESPONSIBILITIES include, but not limited to:
- Ensure and monitor regulatory and standard alignment and compliance to site, regional and Global processes and execution.
- Support the maintenance of regulatory compliance, record-keeping, and certifications for agencies including UL, FDA, FM, and CSA.
- Implement and oversee complex QMS processes, regulatory requirements, and certifications, including ISO 27001/27002, 9001, ISO 13485, AS 9100, etc. and IPC standards.
- Provide internal audit support for shared services functions and sites where assigned.
- Manage Global Risk Management Processes as BPO
- Perform Customer MSA/Quality Agreement reviews
- Serve as a member of the Global Leadership Team, contributing to the Company’s Vision and Strategy within the business unit.
- Collaborate with sites, regional, and global Quality leaders and external suppliers to resolve issues and share expertise.
- Support key customer accounts by building strong relationships, resolving issues, and collaborating with senior leaders.
- Exercise independent decision-making in technical and financial teams, acting in the customer’s best interest and supporting key quality initiatives.
- Demonstrate expertise in Lean, continuous improvement, and advanced problem-solving to address manufacturing and QMS challenges.
- Track and manage Key Performance Indicators (KPIs) as assigned, driving improvements in quality performance.
- Lead continuous improvement efforts and implement effective solutions to enhance site operations and customer success.
- Provide clear communication across site and regional QMS, business, and customer interactions at all organizational levels.
- Engage and support a strong cross-functional team, fostering a culture aligned with Creation Core Values.
- Participate in Global budgeting processes, including continuous improvement and headcount modeling.
- Exhibit strong leadership, people skills, and effective presentation and communication abilities to influence decision-making processes.
- Travel between business units, customers, suppliers will be required.
- Other duties and responsibilities as assigned
QUALIFICATIONS:
- Bachelor’s Degree required in Quality or Technical Discipline in related discipline preferred
- 7+ years relevant Quality experience in electronics manufacturing or Medical Device/ Aerospace and Defense (A&D) with 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
Strong Requirement:
- Proven experience leading the successful design, implementation, certification, and ongoing governance of an Information Security Management System (ISMS) aligned with ISO 27001 and ISO 27002 standards.
- Demonstrated success establishing and governing enterprise-wide information security programs, including the implementation and continuous improvement of ISO 27001/27002-compliant ISMS frameworks.
- Accountable for information security governance, risk management, policy development, compliance oversight, and audit readiness in accordance with ISO 27001/27002 requirements.
- Experience driving organizational certification efforts, managing internal and external audits, and ensuring sustained compliance with ISO 27001 standards.
- Working Experience with ISO9001, AS9100 and ISO13485/FDA and other applicable standards.
- Ability to manage multiple concurrent projects and to deliver results accurately and on time
- Experience in application of 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 the ability to meet firm deadlines.
- Proven leadership in fostering collaboration, coaching, and mentoring teams.
In accordance with pay transparency regulations, the anticipated starting salary for this position ranges from $125k-$150k USD. Full-time employees are also eligible for performance-based bonuses and a range of benefits. Please note that this salary range is not guaranteed, and the final offer may vary based on experience, education, location, and shift. Additionally, the benefits and programs available may differ depending on the hire date, schedule type, and hours worked.
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Creation Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
If you require any accommodations to complete the application process or need the job posting in an alternative format, please email Accessibility@creationtech.com. You will be connected with our Talent Acquisition team.
If you are contacted regarding the position, please inform our Talent Acquisition team of any accommodations you may need during the recruiting process. All information related to accommodation requests will be handled confidentially.
Canada: Title for the position will be in accordance with applicable national and local laws.
