Medical devices documentation Lead

Mechelen , Flanders, Belgium

Type: n/a

Category: Healthcare & Pharma

Requirements: English
Company: Akkodis
Region: Mechelen , Flanders

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 clients 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 clients 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 clients 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

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