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)
What do we mean by project-based cooperation?
- This is a high-intensity, hands-on project with a clearly defined outcome: a complete, coherent, and audit-ready documentation set aligned with Design Control and QMS requirements. After onboarding, you collaborate with the team to review scope and materials, estimate effort and timelines, and lead the implementation of documentation and system setup once approved by the client. You conclude the engagement by running a handover and training session, ensuring the internal team understands what was delivered, how it’s structured, and how to maintain it going forward.