Experience with a dermatology EMR (e.g., ModMed/EMA) Bilingual (English/Spanish) Front-to-back clinic flexibility - you can...
is a must – understanding of EMA regulations and guidelines is a plus Previous experience in using US innovative expedited paths to approval...
, but not limited to: AWS CWI, API 510, 570, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting...
: Strong understanding of GMP and global regulatory expectations (FDA, EMA, ICH) Experience with multi-site tech transfer...
, guidelines and/or specifications (FDA, EMA, ICH). Ability to initiate and lead large, cross-function projects and see it through...
(preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical...
. Serve as on-the-bench SME during internal audits and regulatory inspections (FDA, EMA, etc.), supporting back-room...
. Ensure site compliance with ISO 13485, FDA, EMA, and applicable global regulations for drug-device combination products...
is highly preferred. Technical Skills: Experience navigating Electronic Medical Records (EMR) systems (knowledge of EMA...
, but not limited to: AWS CWI, API 510, 570, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting...