Quality and Regulatory Associate

Quality & Regulatory Affairs Associate

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Location: Alpharetta, GA

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Position Summary

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A growing subsidiary of a global medical device manufacturer dedicated to delivering innovative, high-quality respiratory products that improve patient care and clinical outcomes. We are seeking a highly organized and detail-oriented Quality & Regulatory Affairs Associate to support quality assurance and regulatory compliance activities for our U.S. operations.

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This role will assist in maintaining the Quality Management System (QMS), ensuring compliance with FDA regulations and applicable quality standards, supporting regulatory documentation, and coordinating quality-related activities across the organization. The ideal candidate will have experience in the medical device, life sciences, or regulated healthcare industry and possess a strong commitment to quality and continuous improvement.

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Essential Duties and Responsibilities

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Quality System Support

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• Support the maintenance and administration of the Quality Management System (QMS) in accordance with FDA regulations.
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• Assist with document control activities, including creation, revision, approval routing, distribution, and archival of controlled documents.
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• Maintain quality records and ensure proper document retention practices.
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• Assist with employee training records and compliance tracking.
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Regulatory Affairs Support

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• Maintain regulatory documentation, product registrations, licenses, and submissions.
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• Support FDA establishment registration and device listing activities.
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• Assist with preparation and compilation of regulatory submissions and technical documentation.
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• Monitor regulatory updates and communicate relevant changes to management.
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Complaint Handling and CAPA

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• Assist in the intake, documentation, and investigation of customer complaints.
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• Support corrective and preventive action (CAPA) activities, including tracking, effectiveness verification, and record maintenance.
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• Participate in root cause investigations and continuous improvement initiatives.
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Audit and Inspection Support

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• Assist in preparing for internal audits, external audits, supplier audits, and FDA inspections.
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• Help collect and organize documentation requested by auditors and regulatory authorities.
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• Track audit findings and support follow-up actions.
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Supplier Quality Support

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• Maintain supplier qualification files and approved supplier lists.
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• Assist in monitoring supplier performance metrics and quality issues.
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• Support supplier corrective action requests and related documentation.
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Quality Metrics and Reporting

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• Collect, analyze, and report quality data and key performance indicators (KPIs).
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• Support management review meetings through preparation of quality reports and trend analyses.
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• Identify opportunities for process improvements and compliance enhancements.
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Cross-Functional Support

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• Collaborate with Operations, Sales, Customer Service, Supply Chain, and Global Quality teams to ensure regulatory and quality requirements are met.
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• Serve as a resource for quality processes and compliance-related questions.
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• Participate in quality improvement projects and special assignments as needed.
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Qualifications

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Required

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• Bachelor's degree in Life Sciences, Biomedical Engineering, Quality Management, Regulatory Affairs, Engineering, or a related field.
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• 1-3 years of experience in a regulated industry, preferably medical devices, pharmaceuticals, diagnostics, or healthcare.
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• Knowledge of quality systems and regulatory requirements.
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• Strong attention to detail and organizational skills.
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• Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint.
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• Excellent verbal and written communication skills.
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• Ability to manage multiple projects and priorities in a fast-paced environment.
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Preferred

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• Experience working within an FDA-regulated environment.
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• Familiarity with:
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• 510(k) Submissions
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• ISO 13485
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• ISO 14971
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• CAPA systems
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• Complaint handling processes
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• Document control systems
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Key Competencies

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• Attention to detail
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• Regulatory compliance awareness
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• Problem-solving and analytical thinking
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• Organization and time management
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• Team collaboration
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• Continuous improvement mindset
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• Professional communication skills
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Physical Requirements

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• Ability to work in an office and warehouse environment as needed.
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• Occasional lifting of materials up to 25 lbs.
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• Ability to travel occasionally for training, audits, or meetings.
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What We Offer

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• Competitive salary and benefits package.
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• Opportunity to gain broad exposure to quality and regulatory functions within the medical device industry.
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• Professional development and certification support.
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• Collaborative environment with opportunities for career advancement.
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Equal Opportunity Employer that is committed to creating an inclusive workplace for all employees.