Ad Hoc Regulatory Affairs Consultant
Boudicca Dx LLC is a consulting firm specializing in in vitro diagnostics. Boudicca is engaged by both Pharma and Diagnostics companies to develop in vitro diagnostic assays for submission and registration to Health Authorities in the US (FDA) and globally.
Boudicca seeks an Ad Hoc Regulatory Affairs Consultant to participate in the coordination of assay development strategies including, but not limited to, preparing and publishing pre-submission documents, IDEs, INDs, responding to Health Authority queries, setting-up and leading meetings with clients and regulatory authorities, including preparing agendas and meeting minutes, etc.
The Regulatory Affairs Consultant will prepare and process all regulatory documentation through the IRB/EC, FDA and all applicable regulatory review including 510(k) submission, De Novo submissions, PMA submissions, pre-submissions, IDEs, INDs, amendments, etc. The Consultant will prepare and process all required regulatory documentation for pharmaceutical companies, diagnostic companies, contract research organizations (CROs), and Health Authorities, as well as organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Consultant is expected to resolve regulatory and data queries as required and participate in initiation, monitoring, audit and close-out clinical trial visits. The Consultant will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Consultant is expected to facilitate the development and submission of FDA IDE and IND applications and annual reports, and as well as to provide direct regulatory/compliance guidance.
Qualifications:
Regulatory Affairs Specialist - Bachelor's degree and 2 to 4 years of experience or an equivalent combination of education and experience required.
If interested, please email contact information, and resume to
info@boudiccadx.com
Boudicca Dx LLC is a consulting firm specializing in in vitro diagnostics. Boudicca is engaged by both Pharma and Diagnostics companies to develop in vitro diagnostic assays for submission and registration to Health Authorities in the US (FDA) and globally.
Boudicca seeks an Ad Hoc Regulatory Affairs Consultant to participate in the coordination of assay development strategies including, but not limited to, preparing and publishing pre-submission documents, IDEs, INDs, responding to Health Authority queries, setting-up and leading meetings with clients and regulatory authorities, including preparing agendas and meeting minutes, etc.
The Regulatory Affairs Consultant will prepare and process all regulatory documentation through the IRB/EC, FDA and all applicable regulatory review including 510(k) submission, De Novo submissions, PMA submissions, pre-submissions, IDEs, INDs, amendments, etc. The Consultant will prepare and process all required regulatory documentation for pharmaceutical companies, diagnostic companies, contract research organizations (CROs), and Health Authorities, as well as organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Consultant is expected to resolve regulatory and data queries as required and participate in initiation, monitoring, audit and close-out clinical trial visits. The Consultant will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Consultant is expected to facilitate the development and submission of FDA IDE and IND applications and annual reports, and as well as to provide direct regulatory/compliance guidance.
Qualifications:
Regulatory Affairs Specialist - Bachelor's degree and 2 to 4 years of experience or an equivalent combination of education and experience required.
If interested, please email contact information, and resume to
info@boudiccadx.com
Proudly powered by Weebly