[Hiring] Quality & Regulatory Affairs Manager @Monterail

Role 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.

Qualifications

• 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).

Requirements

• 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.