ProClinical are working with one of the Top 5 Global Pharmaceutical Companies in their Combination and Medical Devices arm and are seeking experts in various areas including; Technical Development - DHF. Our client is seeking a DHF Technical Development expert to work on a freelance basis for a minimum of 6 months. The project is likely to last 12 months and there is even further possibility of extension beyond that. The position is based in the Basel area and will require you to be on-site for 5 days p/week.
- Run and lead technical development activities for medical devices e.g. Autoinjector, Safety syringes.
- Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
- Ensure device design development in compliance with the regulations and delivered at a high quality
- Consult on the development of medical devices and combination products
- Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.
Skills and Requirements:
- An ideal candidate would have at least 8 years of experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices for parenteral administration.
- The ideal candidate would have experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer.
- Excellent technical writing skills (e.g., Design Controls)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
- Experience in Product Design and Design for Manufacturing
- Good technical knowledge of primary containers development
- Good technical knowledge of autoinjector development
- Good communication skills
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- General understanding of pharmaceutical development
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock on +44 203 0789 554 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.