Regulatory Affairs Specialist -Med Devices

Role - QA/RA Senior Specialist

Location - London

Hours 40 hours Monday to Friday

Salary £50,000 to £60,000

Overview

We are seeking a highly skilled QA/RA Senior Specialist to join our clients team. To succeed in this role, you will bring extensive experience in Quality Assurance and Regulatory Affairs within the Medical Device industry, with a strong command of ISO 13485, regulatory compliance, and post-market requirements.

You will play a key role in maintaining and improving our Quality Management System (QMS), guiding internal and external audits, and ensuring our products meet applicable regulatory standards throughout their lifecycle.

Key Responsibilities

• Develop, implement, and maintain Quality and Regulatory processes in line with applicable regulations and standards (e.g., ISO 13485, MDR).
• Drive continuous improvement initiatives within the QMS.
• Collaborate cross-functionally and with the external subcontractors to ensure ongoing regulatory compliance.
• Provide QA/RA support during changes and product lifecycle management.
• Lead risk management activities and oversee post-market surveillance processes.
• Conduct thorough root cause investigations and manage Corrective and Preventive Actions (CAPA).
• Coordinate the preparation and maintenance of technical and regulatory documentation.
• Develop, maintain, and execute internal and external audit plans to ensure audit readiness and compliance.
• Author, review, and update QMS policies, procedures, and work instructions.
• Monitor and implement regulatory updates, ensuring company compliance with evolving standards.
• Ensure SOPs are appropriately established, implemented, and followed across all functions.
• Deliver internal training to enhance regulatory and quality awareness throughout the organization.

Required Experience, Skills & Qualifications

• Proven Quality Assurance experience in the Medical Device sector.
• Bachelor's degree (or higher) in a scientific or engineering discipline.
• In-depth knowledge of ISO 13485, EU MDR, and global regulatory requirements.
• Demonstrated experience managing internal and external audits, including interaction with regulatory bodies and notified bodies.
• Strong understanding of QMS development, maintenance, and continuous improvement.
• Skilled in compiling and maintaining technical documentation
• Strong analytical, organizational, and communication skills.
• Ability to work independently and collaboratively in a cross-functional environment.

The Ideal Candidate

You are a proactive, detail-oriented QA/RA professional with a passion for maintaining the highest standards of compliance and quality in medical device development. You re a natural collaborator with excellent communication and problem-solving skills, ready to contribute to continuous improvement across both regulatory and quality initiatives.