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Device Documentation Lead
CR/156448_1744797403
Posted: 16/04/2025
- €80 - €89 per hour
- Belgium
- Contract
Device Documentation Lead (12-Month Contract)
Location: Remote (EU, UK or Switzerland based)
About the Role
We are looking for a Device Documentation Lead who is methodical, detail-oriented, and has excellent interrelation skills to join a multidisciplinary team. This is a 12-month contract role that can be based anywhere in EU, UK or Switzerland, as the position is remote.
In this role, you will focus on supporting the creation of Device Documentation for a Drug-Device Combination Product that is currently in development. As a Subject Matter Expert, you will contribute to writing Device Development Documentation and ensure smooth regulatory submissions.
Who You'll Work With
You will report to the Head of Device Transversal Services and work within a highly collaborative global team of technical, quality, regulatory, and safety experts.
What You'll Do
Report Generation: Author or review documents and generate scientific protocols and reports that support the Design History File, Technical Documentation, and Source Reports for regulatory license applications.
Documentation Management: Manage documentation for the drug delivery device in collaboration with partners.
Collaboration: Work in a team environment, collaborating with technical, quality, regulatory, and safety experts.
Regulatory Submissions: Contribute to the preparation of regulatory submissions by coordinating the creation of relevant source reports and managing the review and approval process in the electronic document management system.
Data Integrity: Contribute to the data integrity review of device documentation and CMC sections of regulatory dossiers.
Interested? For this role, we are looking for the following qualifications, experience, and skills:
A Master's degree in a relevant field.
8+ years of experience in Medical Devices and/or Drug-Device Combination Products.
Very good knowledge of medical devices, drug-device combination products, and pharmaceutical environments.
Thorough knowledge of Drug Delivery Devices Regulations: EU MDR, Art 117, GSPR, 21CFR part 820, 21CFR part 4, ISO13485, and GMP.
Excellent English writing skills.
Project Management skills and experience leading cross-functional, matrix teams.
Ability to work autonomously with a strong attention to detail.
Imogen Szerdy
Consultant