Regulatory Affairs & Quality Manager - Medical Devices (m/w/d)

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. 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.

• Regulatory Affairs
• Support regulatory strategy for new and existing medical devices.
• 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.
• 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.
• 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.
• Act as the Quality and Regulatory representative within New Product Development projects.
• Risk Management Files
• Work closely with engineering and production teams to ensure products are designed for manufacturability and regulatory compliance.
• Regulatory submissions.
• Quality procedures and work instructions.

Qualifications:

• 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.
• Experience supporting New Product Development and design transfer projects.
• 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.
• Experience with Class II or Class III medical devices.
• Experience implementing or improving quality systems within a growing organisation.
• Experience scaling regulatory and quality processes to support portfolio growth.

Opportunity to shape the Quality and Regulatory function of a growing medical device business. Genuine opportunity for career progression as the company continues to grow. 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.