Quality Assurance Regulatory Affairs Manager

Position Overview

The Quality & Regulatory Affairs Manager is responsible for ensuring organizational compliance with applicable regulatory requirements while leading and improving customer-facing quality processes. This position plays a critical role in maintaining product and quality compliance, supporting regulatory submissions, managing customer quality concerns and complaints, and coordinating internal and external audits.

The ideal candidate will have extensive experience in quality management, regulatory compliance, manufacturing operations, and ISO quality systems, with strong leadership and problem-solving capabilities.

Key Responsibilities

• Develop, implement, maintain, and oversee regulatory and compliance programs.


• Serve as the primary point of contact for regulatory agencies and customers regarding compliance and product quality matters.


• Partner with Quality Engineering to manage, document, and track customer quality concerns, complaints, and root cause analysis (RCA) activities.


• Lead and coordinate customer complaint resolution across departments, assigning responsibility for root cause analysis and corrective actions.


• Manage customer quality audits and ensure timely and effective follow-up on audit findings.


• Advise management on changes to regulatory requirements and their potential impact on products, processes, and operations.


• Ensure company quality and environmental policies are effectively implemented and that applicable ISO standards and regulatory requirements are met.


• Ensure compliance with applicable FDA regulations for the manufacture of components and medical devices.


• Oversee implementation and compliance of export control programs, including ITAR and EAR requirements.


• Monitor regulatory changes and identify certifications, standards, and compliance programs that will strengthen the organization's ability to meet customer and industry requirements.


• Lead and participate in continuous improvement initiatives focused on improving operational efficiency, reducing waste, and increasing productivity.


• Build and maintain strong professional relationships with customers, suppliers, vendors, and regulatory agencies.


• Promote a culture of continuous improvement, accountability, innovation, and quality excellence throughout the organization.


• Manage the internal audit program, including auditor training, audit scheduling, report review, corrective actions, and follow-up.

Regulatory Affairs

• Prepare, submit, maintain, and manage regulatory filings and documentation.


• Serve as the management representative for applicable regulatory and quality systems.


• Monitor global regulatory developments and ensure continued compliance with applicable requirements, including FDA and ISO 13485 standards.


• Maintain accurate and current regulatory documentation and support internal and external audits and regulatory inspections.


• Collaborate with Product Development, Engineering, Quality, and Operations teams to establish regulatory strategies for new and existing products.


• Monitor and report key quality metrics, including PPM, customer complaints, audit findings, corrective actions, and customer satisfaction indicators.


• Coordinate and host customer quality audits and ensure all resulting actions and documentation are completed in a timely manner.


• Support the review, negotiation, and implementation of customer quality agreements.


• Train, coach, and mentor employees on regulatory compliance, quality systems, environmental requirements, internal auditing, documentation practices, and manufacturing best practices.

Customer Quality Management

• Serve as the primary point of contact for customer quality issues, concerns, and complaints.


• Coordinate cross-functional root cause analysis and CAPA activities to ensure effective corrective and preventive actions.


• Ensure customer complaints are properly investigated, documented, tracked, and resolved.


• Ensure document control processes are effectively implemented and maintained throughout the organization.


• Lead and participate in quality improvement and continuous improvement initiatives.


• Serve as a liaison with customers, suppliers, regulatory agencies, and other external organizations on quality system and continuous improvement matters.


• Work collaboratively with employees at all organizational levels to resolve routine and complex quality issues.


• Drive accountability for timely and effective resolution of customer and internal quality concerns.

Education & Certifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Quality Engineering, or a related technical discipline preferred.


• Advanced degree in a related field is a plus.


• Certifications or formal training in Quality, Lean Manufacturing, Six Sigma, Technical Problem Solving, or Root Cause Analysis preferred.


• Training or certification in regulatory compliance is a plus.


• ISO 13485 Lead Auditor certification is highly desirable.

Experience & Qualifications

• 10+ years of progressive experience in regulatory affairs, quality assurance, or quality management within a manufacturing environment.


• Minimum of 5 years of experience in a quality administration, quality engineering, or quality management role.


• Previous experience as a Quality Manager or in a comparable leadership position is preferred.


• Strong understanding and practical experience with ISO quality management systems.


• Experience with FDA regulations and medical device manufacturing is highly desirable.


• Knowledge of plastic injection molding processes, particularly those supporting medical device manufacturing, is a plus.


• Experience with customer audits, regulatory audits, CAPA, RCA, and internal audit programs.


• Knowledge of workplace safety procedures and manufacturing compliance requirements is a plus.


• Strong proficiency with Microsoft Office, including Excel, Word, PowerPoint, and Outlook.

Personal Characteristics

• Highly organized with exceptional attention to detail.


• Self-motivated with a strong sense of ownership and accountability.


• Positive, professional, and adaptable approach.


• Strong analytical and problem-solving skills.


• Excellent written and verbal communication skills.


• Strong interpersonal and relationship-building abilities.


• Effective team leader and collaborator.


• Ability to work effectively with employees and stakeholders at all levels of the organization.


• Willingness to continuously learn and develop new skills.

Reporting Structure

This position reports to the:

• President


• Director of Engineering


• Director of Operations