Regulatory Affairs Specialist

Overview

Cure Talent is partnering with a reputable medical device manufacturer located in Bromsgrove, Worcestershire, known for a well-established portfolio of Class I and Class IIa devices distributed throughout the UK and European markets. Due to growth, they are seeking a dedicated Regulatory Affairs Specialist to join the Quality & Regulatory team.

Role Purpose and Responsibilities

The Regulatory Affairs Specialist will ensure compliance with UK MDR and EU MDR regulations, supporting the full product lifecycle from development through post-market phases. Close collaboration with the QA Manager is expected to maintain technical documentation, facilitate regulatory submissions, interact with regulatory authorities, and contribute to the enhancement of the Quality Management System.

• Assist in implementing and continuously improving the Quality Management System adhering to ISO 13485 standards.
• Create, review, and update Technical Files, Design Dossiers, and General Safety and Performance Requirement (GSPR) checklists to comply with UK MDR and EU MDR regulations.
• Maintain regulatory compliance documentation for the product range.
• Compile risk management documentation and Clinical Evaluation Reports.
• Coordinate Post Market Surveillance and Post Market Clinical Follow-up activities.
• Engage with MHRA, Notified Bodies, and regulatory partners.
• Support management reviews and prepare for audits by Notified Bodies.
• Track regulatory and standards changes to aid implementation within the organization.
• Provide regulatory advice and training to cross-functional teams.
• Assist with internal and external audit processes as needed.

Required Experience and Qualifications

• Demonstrated experience in Regulatory Affairs in the medical device sector.
• Comprehensive knowledge of UK MDR, EU MDR 2017/745, UKCA marking, and ISO 13485 standards.
• Proficiency in preparing and maintaining Technical Files and regulatory documentation.
• Hands-on experience supporting regulatory submissions and compliance activities.
• Familiarity with Class I and Class IIa medical devices.
• A degree in Life Sciences, Engineering, Biomedical Science, or an allied area.