situations. Medical office experience required. EMA/ModMed experience preferred. Responsibilities include but are not limited...
authorities (FDA, EMA, PMDA) and serve as the primary device subject matter expert (SME) during Pre-Approval Inspections (PAIs...
Agency (EMA) regulations/guidelines and other applicable regulatory requirements. Our company: The work environment...
management systems and databases Familiarity with GMPs and applicable regulations, guidelines (e.g. CFR, EMA...
under ISO 13485 and applicable GxP regulatory frameworks including FDA and EMA guidelines. Your role will enhance our audit... and global GxP regulatory frameworks (FDA, EMA). Fluent in English. Preferred Skills: Advanced degree. ASQ Certification...
is required. Authoring CMC dossiers for FDA, EMA, and other regulatory agencies are desirable. Knowledge and experience in drug-device...
to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved...
and conferences, applying acquired knowledg. Maintain compliance with cGMP, GLP, GCP, FDA, and EMA guidelines whenever applicable... integrity and compliance to company SOPs/policies and specifications, FDA and EMA cGMP regulations, and Virbac safety policy...
and expansion projects. Experience with greenfield pharmaceutical manufacturing site development. Experience supporting FDA, EMA...
and submissions ICH guidelines Other applicable regulatory guidance documents Global PV regulatory environment EMA regulations...