About Akkodis
Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com
Context :
For one of our key pharmaceutical clients, we are seeking a senior documentation writer to support the regulatory documentation activities related to a drug-device combination product developed by a U.S.-based partner. The device is intended for global distribution, requiring compliance with both U.S. (21 CFR Part 4) and European (EU MDR - Article 117) regulations.
The consultant will be responsible for translating and aligning existing device documentation into the client’s internal language, format, and standards, ensuring regulatory readiness for international submissions.
📍 This mission can be fully remote (EU-based).
Key Responsibilities :
* Draft, adapt, and review device documentation in line with ISO 13485 and the client’s internal documentation standards.
* Structure and maintain the Design History File (DHF) and related technical documentation.
* Collaborate with internal stakeholders including Regulatory Affairs, Quality Assurance, CMC, and the U.S. development partner.
* Manage documentation within the client’s electronic document management system (eDMS).
* Contribute to the preparation of regulatory submissions for both U.S. and EU markets.
* Ensure data integrity, traceability, and regulatory compliance across all documentation.
Your Profile :
* Minimum 8 years of experience in the medical device or drug-device combination sector.
* Strong knowledge of international regulatory frameworks:
* 21 CFR Part 4 / Part 820
* EU MDR, including Article 117
* ISO 13485
* Excellent scientific and technical writing skills in English.
* Familiarity with eDMS platforms and GxP environments.
* Self-starter, detail-oriented, and capable of working cross-functionally in an international project setting.
Why join Akkodis?
By joining the AKKODIS team, you will benefit from:
A personalized onboarding process through a mentoring system Career support from your Business Manager Active involvement in your training plan as well as in your personal and professional development A permanent contract A competitive salary package, including several extra-legal benefits