Quality Assurance & Regulatory Affairs (QARA) Manager
Medical Devices
Location: Hertford, Hertfordshire
Contract Type: Contract
About Us
We are an ambitious and rapidly growing medical device company developing innovative products that improve patient outcomes and support healthcare professionals worldwide.
As we continue to expand our product portfolio and international market presence, we are seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead our Quality and Regulatory function and play a critical role in bringing new medical devices to market.
This is an exciting opportunity for someone who thrives in a hands-on SME environment and enjoys building systems, processes, and documentation from the ground up while working closely with engineering, manufacturing, and leadership teams.
The Role
Reporting directly to senior leadership, you will take ownership of Quality Assurance and Regulatory Affairs activities across a growing portfolio of medical devices.
You will be responsible for developing and maintaining technical documentation, supporting product development activities, ensuring regulatory compliance, and driving quality throughout the entire product lifecycle.
We are specifically looking for someone who has experience managing multiple medical device products and projects simultaneously, rather than supporting a single product line.
This role requires a highly collaborative individual who can work effectively with R&D, engineering, manufacturing, suppliers, and external regulatory bodies while helping shape the future quality and regulatory strategy of the business.
Key Responsibilities
Regulatory Affairs
* Lead the creation, maintenance, and submission of EU Technical Documentation and Technical Files from the ground up.
* Support regulatory strategy for new and existing medical devices.
* Prepare and maintain documentation in accordance with MDR (EU 2017/745).
* Coordinate regulatory submissions and product registrations in European and international markets.
* Interface with Notified Bodies, Competent Authorities, and external regulatory consultants.
* Review product changes and assess regulatory impact.
* Maintain regulatory compliance throughout the product lifecycle.
* Support future market expansion activities including UK, EU, US, and other international regions.
Quality Assurance
* Maintain and continuously improve the Quality Management System in accordance with ISO 13485.
* Ensure quality requirements are integrated throughout product design, development, manufacturing, and post-market activities.
* Support supplier qualification and supplier quality activities.
* Lead internal audits and support external audits.
* Ensure effective document control systems are maintained.
* Provide quality and regulatory guidance to cross-functional teams.
* Support implementation of scalable quality processes suitable for a growing business.
New Product Development (NPD)
* Act as the Quality and Regulatory representative within New Product Development projects.
* Participate in design reviews throughout the development lifecycle.
* Ensure Design Control requirements are effectively implemented and maintained.
* Review design documentation including:
* Design Inputs
* Design Outputs
* Verification & Validation documentation
* Risk Management Files
* Clinical Evaluation documentation
* Usability Engineering documentation
* Support design transfer activities from development into manufacturing.
* Work closely with engineering and production teams to ensure products are designed for manufacturability and regulatory compliance.
Technical Documentation
* Author and review:
* Technical Files
* Design Dossiers
* Risk Management Files
* Clinical Evaluation support documentation
* Regulatory submissions
* Product specifications
* Manufacturing documentation
* Quality procedures and work instructions
* Establish documentation structures and processes suitable for a growing product portfolio.
About You
You will be a proactive and technically strong QARA professional who enjoys operating in a fast-paced, entrepreneurial environment.
You will be comfortable rolling up your sleeves and taking ownership while also contributing strategically to the company's future growth.
Essential Experience
* Degree in Engineering, Life Sciences, Medical Devices, Quality, Regulatory Affairs, or a related discipline.
* Significant experience in Quality Assurance and Regulatory Affairs within the medical device industry.
* Proven experience creating EU MDR Technical Documentation and Technical Files from scratch.
* Strong knowledge of:
* EU MDR 2017/745
* ISO 13485
* ISO 14971
* Design Control requirements
* Product development lifecycles
* Experience supporting New Product Development and design transfer projects.
* Experience participating in and leading design reviews.
* Strong technical documentation writing skills.
* Experience managing multiple products and regulatory projects simultaneously.
* Experience working within an SME, start-up, or rapidly growing medical device company.
* Excellent stakeholder management and communication skills.
Highly Desirable
* Experience with Class II or Class III medical devices.
* Experience dealing directly with Notified Bodies.
* Experience supporting international registrations.
* Knowledge of FDA requirements and US market submissions.
* Experience implementing or improving quality systems within a growing organisation.
* Experience scaling regulatory and quality processes to support portfolio growth.
Why Join Us?
* Opportunity to shape the Quality and Regulatory function of a growing medical device business.
* High visibility and direct interaction with senior leadership.
* Influence future product development programmes.
* Work across a diverse and expanding device portfolio.
* Genuine opportunity for career progression as the company continues to grow.
* Collaborative and innovative working environment where your expertise will make a real impact.
If you are an experienced QARA professional looking for an opportunity to build, influence, and drive quality and regulatory excellence within a growing medical device company, we would love to hear from you.