Quality & Regulatory Affairs Manager - Freelancer

Job description

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: What do we mean by project-based cooperation? - 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). - Experience with tools such as Greenlight Guru, Jama , or similar documentation / traceability platforms - Proven experience with retroactive compliance - organizing, completing, and restructuring documentation created “after the fact.” - Ability to audit existing product and technical documentation, identify gaps, and bring it into a coherent, compliant structure. - Hands-on experience preparing and maintaining documentation such as: SRS, SDP, SAD, SDD, Software Test Plans & Test Results, Release Notes, Traceability matrices, versioning, audit-ready structures - Experience coordinating inputs from product, development, and QA teams, and transla...