Hobson Prior are seeking for a Medical Device Consultant to join a fantastic CRO on a permanent basis with the ability to work remotely from anywhere in Europe. Our client is focused on offering a variety of services to ensure life-saving medicines get to patients quicker.

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

Key Responsibilities:

• Recognise assisting documents needed for international proposals and deliberate the distribution of approved technical source documents rendering to project timelines.
• Guarantee efficient communication of CMC/device regulatory methods, risks, and general plan for designated products.
• For this position, you will be accountable for authoring regional and international CMC/device documentation for proposals aligned with approved international regulatory methods, as well as within approved timelines.
• Guide or offer assistance to cross-functional teams accountable for planning replies to HA CMC/device queries escalated in regions allocated for designated projects/products.
• You will serve as a regulatory CMC/device regional representative for allocated projects/products.
• The ideal candidate will offer regulatory affairs CMC/device contributions for allocated projects/products.
• You will highlight predicted and current crucial concerns escalating through the product lifecycle in a timely fashion.
• Any other assigned duties.

Requirements:

• Educated to a degree level.
• Familiarity with registration obtained by working within a pharmaceutical organisation or regulatory authority in one of the ICH regions on development and post-approval products.
• Acquaintance with contributing to regulatory agency meetings on CMC & Devices concerns would be ideal.
• Background in writing and partaking in the distribution of GRA-CMC module 3 sections of marketing authorisations and IMPD/IND.
• Know-how of GMP needs and standard systems such as change management systems and tools.
• At least 5 years of experience in a regulatory CMC/device role.
• Knowledge of IVD, SaMD and/or combination products, in IVD testing or CDx development.
• Experience with IVD, MDR, 510(k) and IMDRF needs as well as SaMD.
• Expertise on Software as a Medical Device development.
• Past involvement with digital sensors, RTTE, data privacy and cybersecurity need and Combination products such as inhalation devices, syringes, auto injectors, etc.

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.