Senior Documentation Engineer - Primary Packaging & Medical Devices | Senior Documentation Engineer - Primary Packaging & Medical Devices

Job Summary

The Senior Documentation Engineer will be instrumental in ensuring regulatory compliance and documentation integrity for primary packaging materials, medical devices, and combination products within a dynamic pharmaceutical setting. A core function involves maintaining and updating Design History Files (DHF) for legacy products and strictly adhering to critical regulatory standards, including ISO 13485, 21CFR820, and the EU MDR. Day-to-day tasks involve creating, reviewing, and approving essential Design Control documents, such as verification/validation protocols and comprehensive risk management plans. You will collaborate cross-functionally with Regulatory, QA, and Manufacturing teams to manage design changes and compliance projects effectively. This role requires a strong scientific background in drug delivery systems and profound experience in medical device development, offering a chance to contribute to strategically vital projects focused on continuous product lifecycle improvement.