Search results for “tech”

Jobs

CER/Technical File Gap Assessment Consultant (224517)

A BDN client is looking for a CER/Technical File Gap Assessment Consultant who will conduct a Technical File gap assessment for MEDDEV Rev. 4 compliance and EU MDR compliance as well as a Clinical Evaluation Gap Assessment for MEDDEV Rev. 4 and EU MDR compliance for products from the client’s facility. The two products are software devices (Class IIa in EU), and two CERs exist (one for each product), and the technical files are in the Medical Devices site (will establish file/document secured sharing electronically and there will be a point person in Medical Device site for questions and assistance with obtaining documents.)

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Remote
Medical/Technical Writer (224478)

A BDN client is looking for a Medical/Technical Writer who has a background with genetic sequencing. This role is not working on submissions but will be working on writing for clinical utility protocols and validation studies. IVD products will be classified as a Medical Device, but the client needs a consultant who has a strong scientific background with genetic sequencing experience. An IVD background is a plus; Scientific knowledge is vital for this position. This candidate will be working on synthesizing validation data from the IVD team into presentable summaries.

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West Coast
Technical Operations Project Manager (224489)

A BDN client is looking for a Technical Operations Project Manager who will assist in the management of technical product team (TPT) sub-teams in a cross-functional team-based environment. The successful candidate will partner as a Technical Product Team Leader and TPT team members to provide Project Management (PM) support to the TPT Team/sub-teams. Scheduling and coordinating team meetings, preparing and/or coordinating pre-meeting materials, meeting agenda, and minutes are needed. Maintaining project timelines, monitoring project tasks, and completion status for designated projects is essential.

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West Coast