Location: Paris, FR (3 days onsite/2 days remote)
Duration: 6 months plus
Description:
The client is preparing for a BLA submission for one of their combination products and although the team has extensive pharmaceutical/biologic expertise, the team lacks device/combination product expertise. The client needs a risk management/design control consultant to help prepare the content for the Design History File and other items included in the product submission/filing. Specifically, the consultant will need to have expertise in risk management, design control and ISO 13485 and 14971 requirements and preferably have combination device product experience, and work on defining and development of the DFMEA & PFMEA documentation. This would include obtaining all required inputs, preparing the templates/drafts, and working through to final approval. Additionally, the consultant will also help to put in place processes and draft SOPs, work instructions, etc. for risk management and ensure compliance with standards. The consultant must have proficiency in both English and French as some of the documentation will be in French.
EU (Hybrid): Risk Management/Design Control Contractor (235951)
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