QA​/RA Analyst

SUMMARY

The QA/RA Analyst is a dual-function role supporting both Quality Assurance and Regulatory Affairs with balanced responsibility across Quality Systems and global regulatory compliance. This position contributes to the maintenance of the Quality Management System and supports regulatory activities across the product lifecycle, including technical documentation, post-market compliance, and global market requirements. As EPI continues to expand its global presence and advance next-generation medical device technologies, this role will support the development of scalable, compliant quality and regulatory frameworks.

• Monitor product operations and quality data to ensure adherence to product specifications and quality standards.
• Support product nonconformance activities including identification, investigations, root cause analysis and implementation of corrective actions.
• Contribute to company Corrective and Prevention Action (CAPA) activities including documentation, execution support and verification of effectiveness.
• Drive post‑market surveillance activities, ensuring timely complaint investigations, trend analysis, and risk management activities.
• Analyze QA/RA metrics (e.g. complaints, CAPA, audit findings, nonconformances, supplier performance) to identify trends and support data‑driven decision making.
• Support supplier quality activities, including qualifications, audits, and ongoing performance monitoring.

• Support development and execution of regulatory strategies for U.S. FDA, EU MDR, and other international markets across the product lifecycle.
• Prepare, maintain, and update technical documentation (e.g. Medical Device Files, Technical Files) under direction of management, ensuring accuracy and compliance with applicable requirements.
• Assess regulatory impact of product and process changes, supporting required submissions, notifications, and regulatory actions.
• Contribute regulatory compliance activities, including adverse event reporting, field actions, and recall support in alignment with global regulatory requirements.
• Monitor changes in applicable regulatory requirements and standards, supporting implementation of updates across the organization.
• Collaborate with cross‑functional teams (Engineering, Operations, R&D) to support product development and commercialization.

• Contribute to maintaining the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820 and other applicable regulatory requirements.
• Perform internal audit activities, including planning, execution, documentation of findings, and follow‑up on corrective actions.
• Ensure compliance with Unique Device Identification (UDI) requirements, including assignment, verification, and regulatory database submissions.
• Support external audits and regulatory inspections (front room), including coordination, documentation readiness, and response preparation.
• Conduct detailed review of key quality and regulatory records to ensure data integrity and inspection readiness.
• Perform other duties as needed to support the QA/RA Department.

• Minimum 3-4 years' experience in a regulated industry (e.g., medical devices, biotechnology).
• 2-3 years of experience in Quality Assurance and Regulatory Affairs activities.
• Bachelor’s degree in a science, engineering, or medically related discipline preferred.
• Cross functional experience in R&D, operations, or manufacturing activities in a regulated field preferred.
• Working knowledge of global regulatory frameworks including:
  • U.S. FDA (21 CFCR 820)
  • EU Medical Device Regulation (EU MDR 2017/745)
  • Other international regulatory requirements (e.g., Health Canada, MHRA)
• Communication skills to convey information in reports, meetings, and status reports.
• Attention to detail and documentation accuracy.
• Strong analytical, critical‑thinking, and problem‑solving skills.
• Effective interpersonal skills and ability to collaborate across departments.
• Ability to manage deadlines while maintaining compliance and quality standards.

• Weekend work may be required on occasion.
• Hybrid work environment with on‑site and…