The Consultant "Medical Device" supports the device parts of drug-device combination products, In Vitro diagnostics and companion diagnostics in a drug development environment.
Tasks & Responsibilities:
- Provide advice to clients on technical, quality, clinical aspects of drug-device combination product development in close collaboration with cross-functional experts from the team.
- Ensure that content of medical device work-packages and documentation are appropriate and enable CE certification and perform gap analyses for regulatory compliance.
- Support Notified Body submissions (including NBOp as per MDR Art. 117, clinical investigation, 510(k))
- Preparation of device-related module-3 sections for MAA and BLA/NDA submissions of drug-device combination products regulated as medicinal products
- Prepare briefing packages for meetings with Notified Bodies and agencies and conduct such meetings together with the client
- Management of operational and strategical aspects with CMOs
Requirements:
- Ph.D. or master's degree and at least five years experience in the field including experience in drug development
- Experience with regulatory filings (technical documentation for CE-certification & STED/application for clinical investigations/pre-RFD/RFP/IDE/De Novo/510(k)/PMA)
- In depth understanding of medical devices (MDR, IVD, IVDR; 21 CFR Part 820) and QA (ISO 13485)
- Experience with medical devices and regulatory requirements for all device life-cycle stages and with relevant processes including risk management and usability engineering
- Team player with strong interpersonal abilities and excellent communication skills in English.
