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 our client, you will play a key role in maintaining and developing their Business Management Systems and ensuring that all their in-vitro diagnostic medical devices meet stringent UK, EU, and international regulatory requirements. Your work will be central to supporting their commitment to quality, compliance, and continuous improvement, helping to safeguard the integrity of their products and processes.

Drawing on your expertise in ISO 17025 and wider regulatory frameworks, you will take ownership of their 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 they do.

Whether maintaining technical documentation, leading management reviews, or liaising with regulatory bodies, you will play a vital part in ensuring that our client continues to meet and exceed regulatory expectations while fostering a culture of accountability and excellence. You will also contribute to shaping their 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 them 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.
• To ensure continued regulatory compliance of all in-vitro diagnostic medical devices manufactured and sold by our client 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.

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 client’s careers website to complete your application.