We are looking for a Quality & Regulatory Affairs Manager (freelancer) for a focused, 3-month freelance engagement. The primary objective is the retroactive normalisation and completion of our technical SaMD documentation. What you need: Strong hands-on experience with MedTech / SaMD software documentation , preferably in products preparing for certification. Deep practical knowledge of Design Control Systems and QMS requirements for medical software ( ISO 13485, FDA software expectations). Exp…