Manager of Regulatory Affairs & Customer Quality Pay Range: $75,000.00 – $90,000.00 per year Job description: 1.0 PURPOSE • To ensure organizational compliance with applicable regulatory requirements while managing and improving customer-facing quality processes. This position plays a critical role in maintaining product compliance, supporting regulatory submissions, and serving as the main point of contact for all customer quality concerns, complaints, and audits. 2.0 RESPONSIBILITIES/AUTHORITY • Responsible for the development, maintenance, and oversight of regulatory and compliance programs. • Contact person to interface directly with regulatory agencies and customers on matters related to compliance and product quality. • Works with Quality Engineer as main point of contact for customer quality concerns for the purpose of working on, logging and tracking RCA activities. • Manages and coordinates customer complaint resolution activities across departments assigning the person(s) responsible for root cause analysis (RCA). • Manages customer audits and ensures timely and accurate follow-up on findings. • Advises management on changes to regulatory requirements and their impact on products and operations. • Ensures the company’s quality and environmental policies are implemented and the requirements of their ISO standards and regulations are met. • Ensures that the company meets the FDA regulations and requirements as a manufacturer of components or medical devices. • Ensures that regulations of export control compliance (ITAR and EAR) programs are implemented and are being followed. • Identifies changes to regulations and next certifications the company should pursue to keep the organization at the forefront of customer requirements, or desired compliance. • Leads or actively participates in continuous improvement initiatives aimed at enhancing operational efficiency, reducing waste, and driving productivity across the organization. • Fosters and maintains strong, professional relationships with customers, vendors, and regulatory agencies to ensure alignment, trust, and compliance. • Promotes a culture of continuous improvement by challenging existing processes and behaviors, encouraging innovation, and reinforcing accountability for enterprise-wide quality and performance excellence. • Responsible for internal audit programs, training internal auditors, scheduling audits, reviewing reports and corrective actions. 3.0 DUTIES Regulatory Affairs: • Prepare, submit, and maintain regulatory filings. • Management representative and monitor of global regulatory trends and ensure ongoing compliance with applicable standards (FDA, ISO 13485, etc.). • Maintain and create up-to-date regulatory documentation and support internal/external audits and inspections. • Collaborate and train product development and quality teams to define regulatory strategies for new and existing products. • Track and report key quality metrics such as PPM, complaint trends, audit findings, and customer satisfaction indicators. • Coordinate and host customer quality audits and follow through on required actions and documentation. • Support the negotiation, review, and execution of customer quality agreements. • Trains, coaches and mentors’ personnel to raise level of understanding of concepts related to regulatory compliance, quality, environmental systems, internal auditing, and good practices in documentation and manufacturing. Customer Quality Management: • Serve as the primary contact and coordinator for customer quality issues/complaints. • Coordinate root cause analysis and implement CAPAs within the enterprise using cross functional teamwork to maintain high customer satisfaction ratings and implement effective corrective actions. • Ensure that the documentation control process is implemented and followed by the organization. • Promotes, leads and participates in quality and continuous improvement activities. • Serves as liaison to external parties in matters related to quality systems and continuous improvement projects. • Works with personnel at all levels to solve routine and special issues. 4.0 EDUCATION • Bachelor of Science Degree preferably in Mechanical or Manufacturing Engineering. An Advanced Degree in related discipline a plus. • Management and Problem-Solving Techniques courses such as: Certifications in Quality, Lean Manufacturing, Six Sigma, Technical Problem Solving or Root Cause Analysis. • Training in compliance/regulatory programs a plus. • Certified ISO 13485 Lead Auditor a plus. 5.0 EXPERIENCE • 10 + years in management level regulatory or quality assurance roles in a manufacturing operation setting with a diverse well-rounded background. • Minimum of 5 years in Quality administration or engineering role. Experience as Quality Manager and understanding of ISO Quality systems required. • Knowledge of plastic injection molding processes related to medical devices a plus. • Strong knowledge of safety procedures and policies a plus. • Microsoft Office skills required (Excel, Word, PowerPoint, Outlook, etc). 6.0 PERSONAL CHARACTERISTICS • Highly organized, a positive attitude with attention to detail. • A highly self-motivated person. • Willingness to learn and evolve skillsets. • Excellent written and verbal communication skills. • Strong interpersonal skills and a team builder. 7.0 REPORTING RELATIONSHIP • President, Director of Engineering, Director of Operations Benefits: • 401(k) • 401(k) matching • Dental insurance • Employee assistance program • Health insurance • Life insurance • Paid time off • Professional development assistance • Tuition reimbursement • Vision insurance Work Location: In person