Quality & Regulatory Affairs Manager - Freelancer

3 weeks ago
Contract
Senior
Quality Assurance and Testing
Monterail

Monterail

Monterail specializes in AI-enhanced custom software development, providing scalable web and mobile applications tailored for startups and businesses, backed by a team of over 200 experienced developers, designers, and QA experts.

Internet Software & Services
251-1K
Founded 2010

Description

  • Audit existing product and technical documentation to identify gaps and inconsistencies.
  • Normalize, complete, and restructure documentation into a coherent, compliant format.
  • Prepare and maintain key SaMD documentation artefacts, including SRS, SDP, SAD, SDD, software test plans, test results, release notes, and traceability matrices.
  • Ensure documentation aligns with Design Control System and QMS requirements for medical software.
  • Translate inputs from product, development, and QA teams into compliant documentation artefacts.
  • Set up and maintain versioning and audit-ready documentation structures.
  • Collaborate with the team to review scope, materials, effort estimates, and timelines.
  • Lead implementation of the documentation and system setup once approved.
  • Run handover and training sessions for the internal team at project closeout.

Requirements

  • Strong hands-on experience with MedTech / SaMD software documentation, preferably for products preparing for certification.
  • Deep practical knowledge of Design Control Systems and QMS requirements for medical software, including ISO 13485 and FDA software expectations.
  • Experience with tools such as Greenlight Guru, Jama, or similar documentation and traceability platforms.
  • Proven experience with retroactive compliance and documentation created after the fact.
  • Ability to identify documentation gaps and bring existing materials into a compliant structure.
  • Hands-on experience with SRS, SDP, SAD, SDD, software test plans, test results, release notes, traceability matrices, versioning, and audit-ready structures.
  • Experience coordinating with product, development, and QA teams.
  • Strong ownership mindset and execution-focused approach.
  • English proficiency sufficient for audit-ready documentation and work with international standards.
  • Availability for a defined 2-3 month project period on a B2B basis.

Interested in this position?

Apply directly on the company website

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