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A BDN client is looking for an Electronics/FPGA Consultant who will specify & design all aspects of electronic development. The client is looking for candidates with multiple years of experience as a designer of electronic functions and sub-systems, including experience with working in multidisciplinary design teams to establish agreement on specifications. A technical knowledge of electronics with basic knowledge of Physics, Mechanics, Mechatronics, and software is preferred.

A BDN client is looking for a strong quality auditor with significant Medical Device experience that can perform a qualification audit for a vendor located in Germany. The audit will be related to a potential vendor that would help with the development of a Medical Device product, so the client needs the auditor to have a strong understanding of quality systems for Medical Devices including part 820, ISO 13485:2016, etc.

A BDN client is looking for a Biocompatibility Consultant on the Medical Device side of things. This individual will coordinate testing, review existing data, and write protocols. He/she has to be knowledgeable with Medical Device Toxicology & Biocompatibility, conducting safety assessments of materials, and have ISO 10993 expertise. Working with site staff to locate and review existing technical file/design dossier/ design history file documentation and the supporting product, Biocompatibility, manufacturing processes, sterilization, packaging and/or cleaning validation information for MDR transformation is needed.

A BDN client is looking for a Regulatory CMC Lead to help prepare for an IND submission and is looking for a Mid to Senior level Regulatory CMC Lead consultant with experience in Regulatory CMC submissions, writing, supporting, and reviewing the module 3 section. Skills for this position include Regulatory CMC Submissions, Module 3 (Support / Review), IND, and Start-Up Environment. Pluses for this role include Gene Therapy / Cell Therapy experience. A Bachelor's Degree or higher is preferred for this consultant position.

A BDN client is looking for an experienced Medical Science Liaison (MSL) to help to create/draft and develop compliant policies and procedures around the utilization of MSLs, opinion leader engagement, scientific education, etc. In addition, the client would like the consultant to advise on training, implementation of procedures/policies and pass on an understanding of the guidelines and regulations and where the future is heading.

A BDN client is looking for a Regulatory Project Manager to help prepare for the launch of 2 new NDA's. The client is in need of someone who can take the reigns and own an NDA submission. This individual will manage the submission tracker and be able to effectively communicate timelines back to the executive team. This Project Manager (PM) will be able to escalate issues, risks and project change requests to ensure on-time project delivery.

A BDN client is looking for an Inspection Readiness Auditor to perform an inspection readiness exercise at one of their CMO’s located in Spain. The CMO performs DS Manufacturing and analytical and stability testing, and the client will need a consultant (possibly two) with a strong background and experience working with inspection readiness exercises/remediation.

A BDN client is looking for a QMS Consultant to conduct a comprehensive Gap Assessment of their current Quality Management System (QMS) to support global Medical Device development and commercialization aligned with the latest industry standards. In addition, a detailed project plan will be developed outlining the scope, schedule, and resources required to complete the project. Responsibilities for this position include a complete review of QMS and all existing related documentation, procedures, policies, and interviewing of key personnel.

A BDN client is looking for an experienced Senior Hardware Design Engineer who will be performing duties requiring the application of state of the art professional engineering knowledge. Skills for this position include the ability to read, analyze, and interpret general technical periodicals, professional journals, technical procedures and/or government standards. The ability to write reports, correspond professionally and to write procedure documentation is desired.

A BDN client is looking for a CMC Regulatory Affairs Consultant who will be responsible for supporting the CMC Regulatory Affairs team in developing, coordinating, and implementing global CMC regulatory strategies for assigned programs and tasks. Specifically, the contractor will be supporting the CMC Regulatory Affairs team in defining and optimizing global organizational strategy pertaining to the development, registration, commercialization, and lifecycle management in the United States and international markets.