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.

Specific Responsibilities

• Implement, develop and apply all aspects of a business system that complies with the standards ISO 17025, ISO 14001, ISO 27001, ISO 13485, ISO 9001, RISQS and applicable regulatory requirements.
• Report on the performance of the business system to top management
• 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
• Maintain current knowledge of relevant UK, EU and worldwide regulations (i.e. EU Directive 98/79/EC, EU Regulation 2017/746).
• Develop a robust audit schedule and perform internal audits within a planned timescale. Key involvement in all audits and production of audit reports.
• Prepare Technical Documentation for new products and submit to regulatory bodies (Notified Body/Competent Authority) as required.
• Maintain Technical Documentation for existing products.
• Provide regulatory guidance to other departments within Matrix Diagnostics Ltd to ensure that information is correctly interpreted.
• Develop regulatory strategies and implementation plans for future submissions.
• 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.
  
• Monitoring of non-conformity (NC). Specifically, NC close outs to be investigated thoroughly and conducted in a timely manner.
• Monitoring of emerging trends regarding medical device industry regulations, standards, guidance, and best practices.
• Establish procedures for the preparation and submission of EU Technical Documentation.
• Monitoring and maintenance of risk management files.
• Management and maintenance of the post market surveillance system.
• Participation in investigations of customer complaints, adverse events and feedback.
• Monitoring of complaint processing systems to ensure effective and timely resolution of all complaints.
• Reviewing materials such as marketing literature or user manuals to ensure that the relevant regulatory requirements are met.
• Monitoring of change control; ensuring changes are logged and reviewed for impact on the business management systems and are closed in a timely manner.
• Monitoring of planned deviations, risks and opportunities.
• Maintenance of the document control system.
• Liaison of business management system information to the organisation.
• Participation in investigations of customer complaints and feedback.
• Conducting regular management review.
• Monitoring the outcomes of Internal Quality Control, external and internal Proficiency Testing monitoring activities.
• Production of management reports as required.
• Training of staff on relevant aspect of the business management systems.
• Liaise with compliance and regulatory bodies where required.
• Providing responses to regulatory bodies (including Notified Bodies and National Competent Authorities) regarding product information or issues.
• For the role of QMS Management Representative (ISO 13485):
  -Ensuring that processes needed for the QMS are documented
  -Reporting to top management on the effectiveness of the QMS and any need for improvement
  -Ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements through the organisation

• To be the person Responsible for Regulatory Compliance for the company
  

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