RA/QA Associate

Description

The Regulatory Affairs / Quality Assurance (RA/QA) Associate supports the company’s compliance with global medical device regulations and internal quality system requirements. This role plays a key part in complaint handling, regulatory reporting, document control, calibration oversight, and a variety of quality and administrative activities that ensure products meet applicable standards and customer expectations.

Essential Functions:

• Complaint Handling & Regulatory
• Receive, document, and process product complaints in accordance with applicable country specific regulations and ISO requirements.
• Conduct complaint investigations, coordinate with cross-functional teams, and ensure timely closure
• Assess complaints for potential adverse event reporting; support preparationand submission of MDRs, vigilance reports, and other regulatory notifications
• Maintain complaint files, trend data, and support periodic reporting to management. 

Quality Management System (QMS) Support

• Serve as Document Control Coordinator, managing creation, revision, approval, and archival of controlled documents (SOPs, forms, work instructions, etc.).
• Ensure QMS documentation complies with internal procedures and regulatory standards.
• Serve as the administrator of the QMS software
• Assist with internal and external audits, conducting audits including evidence gathering and assessing compliance with applicable regulations and standards

Calibration & Equipment Control

•  Maintain the calibration program for measurement and monitoring equipment.
• Coordinate calibration activities with internal teams and external vendors.
• Track calibration status, maintain calibration records, and escalate overdue or out-of-tolerance conditions   

Regulator Affairs/Quality Support

• Perform additional duties to support RA/QA leadership and overall compliance initiatives.

Requirements

•   Working knowledge of Medical device complaint handling requirements per applicable country specific regulations and ISO requirements.
• Strong organizational skills with attention to detail and accuracy.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with QMS software, document control systems, and Microsoft Office tools.
• Excellent written and verbal communication skills.
• Regulatory & Quality Compliance – Understands and applies regulatory requirements.
• Documentation Excellence – Produces clear, accurate, and audit-ready records.
• Problem Solving – Supports investigations and root-cause analysis.
• Collaboration – Works effectively with engineering, operations, customer service, and leadership.

Education and Experience:

• 1–3 years of experience in RA, QA, or manufacturing within a regulated industry

(medical device preferred).

• Associate’s degree in a scientific, engineering, or related discipline preferred.

Physical Requirements:

• Sedentary with periods of standing, walking, bending, stooping or lifting up to 35 lbs.