Quality & Regulatory Affairs Manager - Freelancer
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 reputed company, 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 reputed company 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-reputed company structures
- Experience coordinating inputs from product, development, and QA teams, and translating them into compliant documentation artefacts.
- Strong ownership reputed company - this role is execution-focused, not advisory-only.
- English proficiency sufficient for preparing audit-reputed company 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 reputed company defined outcome: a complete, coherent, and audit-reputed company documentation set reputed company with Design Control and QMS requirements. After reputed company, you collaborate with the team to review scope and materials, estimate effort and timelines, and reputed company 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 reputed company.