Quality and Regulatory Specialist Join a dynamic team where innovation and excellence in the medical technology field come to life! As a Quality and Regulatory Specialist, you will be crucial in maintaining our high standards and ensuring compliance with industry regulations. Become part of a team that thrives on innovation and is dedicated to delivering the highest quality solutions for surgical applications. In this exciting position, you will engage in a variety of responsibilities, from overseeing internal and external audits to processing complaints and collaborating on regulatory projects. Your contributions will help shape the future of the client's product portfolio, ensuring that it continues to lead the market with excellence. Key Responsibilities Maintaining and continuously developing the quality management system in accordance with ISO 13485 and MDSAP Preparation and implementation of internal and external audits and monitoring of certification processes Complaint processing Planning, implementation, and monitoring of validation and verification activities Creation and maintenance of technical documentation in accordance with MDR Internal and external contact for regulatory issues and projects Documentation and evaluation of quality indicators for the continuous improvement of our products and processes Compilation of registration documents for international registrations Contact person for regulatory authorities Required Qualifications and Skills Degree in engineering, medical technology, quality management, or a comparable qualification 3 years of professional experience in a regulatory environment and experience in quality management, ideally in medical technology Knowledge of ISO 13485 Analytical thinking as well as a structured and independent way of working High level of reliability and initiative Good presentation, moderation, and communication skills Independent and at the same time team-oriented way of working Benefits and Perks 30 vacation days Flexible hours Bike leasing Balanced male/female ratio (2:2) Actively growing R&D function and product portfolio Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world, and are ready to support your career development with them. Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150 Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence. If you are interested in this role, please apply with your CV or contact Alisa Liddell for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry. alisa.liddell@adaptivelifescience.com 49 30 16638376