Regulatory Affairs Specialist II

About the role

The Regulatory Affairs Specialist II provides essential support to Regulatory Affairs managers by capturing, archiving, and publishing regulatory documents, and by preparing national and international product registration submissions for Integer owned devices.

Key responsibilities

• Prepare and submit national and international regulatory dossiers for medical devices.
• Review change requests requiring regulatory approval to ensure compliance with global regulations.
• Maintain regulatory files, external databases (e.g., FDA FURLS, GUDID, EUDAMED) and product documentation in line with Integer’s quality system.
• Coordinate responses to customer queries, track notifications of changes, and obtain external regulatory documents.
• Support internal quality system audits and participate in external Notified Body audits, compiling and tracking findings.
• Contribute to quality‑system projects, investigating process‑improvement opportunities and ensuring adherence to the Quality Management System.

Required profile

• Experience preparing regulatory submissions for medical devices.
• Familiarity with FDA, EU (EUDAMED) and other international regulatory frameworks.
• Understanding of Quality Management System (QMS) requirements and documentation practices.
• Ability to collaborate with cross‑functional teams and manage detailed tracking logs.
• Strong attention to detail and ability to handle regulatory documentation and archiving.

Required skills

• FDA FURLS database usage
• GUDID database usage
• EUDAMED database usage
• Regulatory database management
• Quality Management System (QMS) compliance