Manager of Regulatory Affairs and Customer Quality

gpac; Watertown (CT); On-site; USD 110,000 - 160,000; Full time

Job summary

gpac in Connecticut seeks an experienced Regulatory Affairs Manager to lead regulatory and compliance programs for medical device components. You will interface with regulatory agencies and customers, oversee audits, and coordinate CAPA and root cause analyses.

The role requires a strong background in ISO 13485, FDA regulations, and export controls, with 10+ years in management. You will mentor teams and drive continuous improvement across operations.

Qualifications

• 10+ years in regulatory or quality leadership within manufacturing.
• Experience with FDA regulations and ISO 13485 frameworks.
• Auditing programs, CAPA processes, and regulatory strategy.

Responsibilities

• Develop, maintain, and oversee regulatory/compliance programs.
• Interface with regulatory agencies and customers on quality matters.
• Lead customer audits, track findings, and ensure timely follow-up.
• Coordinate RCA, CAPA, and cross-department actions.
• Promote continuous improvement and regulatory changes awareness.

Skills

Regulatory compliance

Quality systems

Auditing

CAPA

Root cause analysis

Document control

Continuous improvement

MS Office

Education

BS in Mechanical/Manufacturing Engineering

Advanced degree in related discipline

Certifications in Quality/Lean/Six Sigma

Compliance/regulatory training

ISO 13485 Lead Auditor (plus)

Job description

• 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.

• 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).

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.