Global Audit Manager

Job Title: Global Audit ManagerPlease read the following job description thoroughly to ensure you are the right fit for this role before applying. Location: Lakewood, CO (open to relocation) Schedule: Onsite 9am-5pm Salary: $120,000.00 to $150,000.00 + 10% Annual Bonus Job Description: We are seeking a highly experienced Global Audit Manager to join our team. The ideal candidate will have at least 7 years of experience in Quality Assurance and/or Regulatory Affairs, with a focus on US FDA Class II or Class III medical devices. The role requires expertise in applying global device laws and regulations, particularly in areas such as adverse event reporting and product recalls. A minimum of 2 years of supervisory experience is required, along with proficiency in FDA Quality System Regulations and ISO 13485. Key Responsibilities: Audit Management (Internal, External, Supplier): Lead and manage the Audit function, including internal, external, and supplier audits. This will involve creating annual audit schedules, executing plans, and ensuring audits are conducted according to schedule. Audit Expertise & Regulatory Compliance: Serve as the primary point of contact for regulatory and compliance issues. Provide expertise in audits and inspections, particularly for regulatory bodies such as FDA and Notified Bodies. Ensure that policies and procedures are compliant and effective. QMS Leadership & Improvement: Own, manage, and execute the Quality Management System (QMS) audit processes. This includes remediation of internal audits, supporting regulatory audits, and identifying continuous improvement opportunities. Monitor and report on the health of the QMS area, providing metrics and reporting to senior management and oversight boards. Subject Matter Expert: Act as a Subject Matter Expert and Process Owner for the QMS areas of responsibility during audits and inspections. Host or lead the audit process as required, and ensure that all stakeholders are aligned and compliant. Qualifications: Minimum 7 years of experience in Quality Assurance and/or Regulatory Affairs, with a focus on medical device regulations (US FDA Class II or III). Minimum 2 years of supervisory or managerial experience. Experience leading or hosting regulatory audits (e.g., MDSAP, FDA, Notified Body). Preferred training in FDA Quality System Regulations and ISO 13485. Bachelor's degree in a science related field. This position provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. There is an expansive list of benefits offerings including multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, there is a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. #M3Ref: #558-Scientific

Created: 2025-03-01