Manager Of Regulatory Affairs And Customer Quality

About the Role:

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.

Key Responsibilities

• 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).

• Ensures the company's quality and environmental policies are implemented and the requirements of their ISO standards and regulations are met.

• Prepare, submit, and maintain regulatory filings.

• 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.

Required Qualifications:

• Bachelor of Science Degree preferably in Mechanical or Manufacturing Engineering.

• Minimum of 5 years in Quality administration or engineering role.

• Experience as Quality Manager and understanding of ISO Quality systems required.

Preferred Qualifications:

• 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.

• Knowledge of plastic injection molding processes related to medical devices a plus.

• Strong knowledge of safety procedures and policies a plus.

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. GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.