Quality & Regulatory Affairs Manager - Freelancer

Quality & Regulatory Affairs Manager - Freelancer Key facts LOCATION Remote SEND YOUR RESUME WE'RE COMMITTED TO PROTECTING YOUR PRIVACY. TO SEE HOW WE'LL PROCESS YOUR DATA, PLEASE REVIEW OUR PRIVACY POLICY FOR CANDIDATES EMPLOYEES AND ASSOCIATES OF MONTERAIL. 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). 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 translating them into compliant documentation artefacts. Strong ownership mindset - this role is execution-focused, not advisory-only. English proficiency sufficient for preparing audit-ready documentation and working with international standards. Availability for cooperation for a defined project period (2-3 months; B2B only)