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Regulatory Affairs Specialist -Med Devices
Job Posted: 2 days ago
Salary: £ 50,000 - 60,000 / Annum
Job Type: Permanent
Location: London
Expire in: a month
Job Description
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 initiativesBefore You Apply
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