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Quality Assurance and Regulatory Affairs Manager
Quality Assurance and Regulatory Affairs Manager
Contract: Permanent, Full-time (40 hours per week), Monday to Friday between 8am and 6pm
Location: Hybrid to Waltham Abbey, EN9 3BZ (on-site one day every two weeks as minimum)
As a Quality and Regulatory Affairs Manager at Matrix Diagnostics Ltd, you will play a key role in maintaining and developing our Business Management Systems and ensuring that all our in-vitro diagnostic medical devices meet stringent UK, EU, and international regulatory requirements. Your work will be central to supporting our commitment to quality, compliance, and continuous improvement, helping to safeguard the integrity of our products and processes.
Drawing on your expertise in ISO 17025 and wider regulatory frameworks, you will take ownership of our Business System Manuals and Technical Documentation, ensuring they remain robust, up to date, and audit ready. As the Management Representative for ISO 13485:2016, you will lead internal audits, monitor regulatory changes, and drive compliance initiatives across the business, working closely with teams to embed quality and regulatory best practices into everything we do.
Whether maintaining technical documentation, leading management reviews, or liaising with regulatory bodies, you will play a vital part in ensuring that Matrix Diagnostics continues to meet and exceed regulatory expectations while fostering a culture of accountability and excellence. You will also contribute to shaping our future regulatory strategy, helping the business to stay ahead of emerging trends and industry developments.
This is an exciting opportunity to make a real impact within a dynamic and supportive environment, helping us to uphold the highest standards of product quality, patient safety, and regulatory compliance.
Main Objectives:
To be responsible for all aspects of the Business System Manuals (Quality, Information Security & Environment) and medical device/in vitro diagnostic medical device regulatory compliance.
To maintain and ensure adequacy and effectiveness of the Business Management Systems at Matrix Diagnostics Ltd.
To ensure continued regulatory compliance of all in-vitro diagnostic medical devices manufactured and sold by Matrix Diagnostics Ltd and manage all technical documentation.
To act as management representative for ISO 13485:2016.
Requirements for this role:
Demonstrable experience of ISO 17025 accreditation within a laboratory environment.
Experience of ISO 9001, ISO 13485, ISO 14001 and ISO 27001.
Demonstrable experience of regulatory management within an in-vitro diagnostic medical device design and manufacturing environment, and analytical quality control processes for medical devices.
Experience of preparation and submission of UK, EU and worldwide Technical Documentation.
Evidence of People Management.
Our Company Benefits:
31 days holiday inclusive of bank holidays, increasing with length of service
Contributory Pension scheme up to 5%
Access to Company benefits and discount portal
Access to a Health Cash Plan
Free eyecare vouchers
Cycle to work scheme
Access to confidential Employee Assistance programme
Interactive mental health and wellbeing app
How To Apply
Interested in this opportunity Click apply and you will be redirected to our careers website to complete your application