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Project Manager Software as Medical Device

  • Job Type

    Full-Time

  • Location

    La Ciotat, France

  • Education

    Minimum 2-year degree (Associate level or higher) in IT, Regulatory Affairs, Biomedical Engineering, or equivalent.

  • Experience

    3 to 5 years of experience in project management for software, ideally medical devices.

  • Required Knowledge

    Knowledge in software engineering is required, and knowledge of software and medical device regulations is a plus.

The Project Manager is responsible for managing and ensuring the compliance of technical files for software considered as medical devices (SaMD). He/she contributes to interdepartmental communication to optimize the registration, certification, and market access processes for products in targeted regions (EU, FDA, etc.).

Main Responsibilities

Management of Technical Files (Technical File/Technical Documentation):
  • Prepare, write, and maintain technical files in accordance with regulatory requirements (MDR in the EU, 21 CFR Part 820 for the FDA, or other regions).
  • Ensure product compliance with applicable standards (e.g., IEC 62304, ISO 82304, ISO 14971, ISO 13485, etc.).
  • Coordinate the development of technical file sections: software architecture, risk analysis, safety and performance, and post-market surveillance.
Project Coordination:
  • Collaborate with R&D, Quality, Product, Marketing, Clinical, and Regulatory teams to ensure software compliance from the design phase (“compliance by design”).
  • Define schedules and priorities in alignment with market launch objectives and in agreement with the project lead.
Interactions with Authorities and Notified Bodies:
  • Contribute to submissions to competent authorities and notified bodies (e.g., CE marking, FDA 510(k), etc.).
Change Documentation:
  • Manage software update plans.

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