Job Description

MEDIMAPS GROUP SA

Location:?Geneva, Switzerland (Hybrid)

Start Date:?ASAP, or as agreed

Contract:?Internship

The Medimaps Group is a pioneering leader in the development of Software as a Medical Device (SaMD) solution, utilizing advanced AI to enhance diagnostic accuracy and improve patient outcomes. With a global presence in the US, Europe, and other regions, we are at the forefront of healthcare innovation, dedicated to transforming medical imaging and advancing bone health diagnostics.

We are currently seeking an INTERN to support the Product Requirements Specialist and work directly with the product management, software development, and RAQA teams. This will be a 2-to-6-month assignment in Geneva.

Reporting directly to the Senior Director of Product and Project Management, the Technical Writer Intern plays an important role to support the Product Requirements Specialist in tasks relating to software requirements, user manual development, translation management and documentation according to medical device regulations.

Key Responsibilities include:

1/ SaMD product development:

Support the Product Requirements Specialist to gather, analyze, and clarify Use requirement specifications (URS), software requirement specifications (SRS), and stakeholder inputs and ensure their review and approval. Engage with Product Managers, Developers, V&V and Regulatory teams to ensure a thorough comprehensiveness and understanding of requirements

2/ Documentation & Structuring:

Support the Product Requirements Specialist to convert high-level business needs into detailed, structured, and traceable requirements Support the Product Requirements Specialist to develop clear Software Requirements Specifications (SRS) that comply with medical device regulatory frameworks, cybersecurity and other relevant standards Maintain documentation rigor per medical device standards (e.g., FDA, ISO 13485)

3/ Regulatory & Compliance Alignment:

Ensure that requirement documentation meets regulatory and quality standards (IEC 62304, FDA CFR 820, ISO 14971 risk management, etc.)

4/ Collaboration & Communication:

Act as a liaison between business stakeholders, software engineers, and RAQA teams.

5/ Traceability Management:

Support the Product Requirements Specialist to maintain traceability from software requirements (URS, SRS) to verification, validation, and risk management activities using JAMA and the Traceability Matrix.

6/ Instructions for Use (IFU):

Support tasks relating to writing clear and concise IFUs (User guide) to the high-quality level and standards required, and collaborate usability testing team and product management for design and improvement of these instructions. Review of Installation guides to the high-quality level and standards required in collaboration with Developers for creation of technical content.

7/ Translations:

Support of management translations with external suppliers and the integration of new languages into the user interface and user guides.

What You Need to Succeed

Studying Bachelor's degree , MS degree in Quality, or Biomedical Engineering or related field; or Information Systems, Information Technology, Computer Science, or other related disciplines applied to Software as Medical Device Development Good knowledge of software tools like Excel, Word and ability to understand new tools Ability to understand and explain technical language Experience in writing technical documents in English Strong analytical skills & details oriented Excellent technical writing skills in English Excellent verbal communication skills "Getting things done", being hands-on and autonomous is natural for you You enjoy thinking outside of your area of work, collaborating actively to implement positive change and GDP solutions

What can you expect from us ?

At Medimaps, we are committed to advancing healthcare through cutting-edge technology. As part of our team, you will have the opportunity to shape the future of medical diagnostics, working in an innovative, fast-paced, and growing organization that is transforming the healthcare landscape.

As we work to develop innovative patient solutions, we also work hard to take care of our teammates' professional development, personal growth and well-being. Working with an international, multi-cultural and socially responsible company with meaningful corporate values, an inspiring mission a genuinely great bunch of talented, professional and friendly colleagues.

More specifically, as an intern you will have the opportunity to grow and develop your skills in a fast paced, MedTech environment in preparation for your future career.

Your compensation and benefits package at Medimaps will include:

Intern salary Remote / Hybrid work options 25 days' vacation per year (applied pro rata) Eco friendly allowance for using environmentally friendly transport options Swibeco lunch card - CHF180 per month
Job Types: 100%, Internship
Contract length: 6 months

Work Location: In person

Expected Start Date: 01/07/2025