Device - Drug

Hobson Prior are seeking for a Device - Drug consultant to join a fantastic consultancy on a permanent basis located in Munich. For more information, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will offer advice to clients on technical, quality, and clinical aspects of drug-device combination product development working alongside cross-functional experts from the team.
• Guarantee that content of medical device work-packages and documentation are suitable and facilitate CE certification.
• Conduct gap analysis for regulatory compliance.
• Assist informed body proposals which involves including NBOp as per MDR Art. 117, clinical investigation, 510(k), etc.
• You will prepare device-connected module-3 sections for MAA and BLA/NDA proposals of drug-device combination products regulated as medicinal products.
• The ideal candidate will prepare briefing packages for meetings with informed bodies and agencies and perform said meetings together with the client.
• Responsible for management of operational and tactical facets with CMOs.

Requirements:

• Educated to an advanced degree level with at least 5 years of experience in the field which involves drug development.
• Familiarity with regulatory archiving such as technical documentation for CE-certification & STED/application for clinical investigations/pre-RFD/RFP/IDE/De Novo/510(k)/PMA.
• Comprehension of medical devices such as MDR, IVD, IVDR; 21 CFR Part 820 and QA such as ISO 13485.
• Past involvement working with medical devices and regulatory needs for all device lifecycle stages and with pertinent procedures which involves risk management and usability engineering.
• Works well in a team.
• Communication skills both verbally and in writing.
• Fluency in the English language.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.