Manager of Regulatory Affairs & Customer Quality
Pay: $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…