Medical Device Regulation, EU In-vitro Device Regulation, EMA Policies 0043 & 0070, & PhRMA/EFPIA Principles for Responsible...
during FDA, EMA, and other global regulatory inspections. Partner with Quality Assurance, Regulatory Affairs, Pharmacovigilance...
, and effective CAPAs Compliance & Regulatory Affairs Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable...
inspections (FDA, EMA). You have experience of the core QMS processes that support QC activities, including deviation management...
manufacturing processes within an FDA and/or EMA regulated environment preferred Experience working in a cleanroom environment...
at your preferred pace Strong clinical support: 1-2 dedicated medical assistants, two exam rooms, and EMA / EMR Stable private...
in dermatology medical office preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly...
. Ensure compliance with HIPAA, OSHA, and all applicable healthcare regulations. Utilize EMA / ModMed EMR for scheduling.... Compliance & Reporting Ensure compliance with HIPAA, OSHA, and all applicable healthcare regulations. Utilize EMA / ModMed EMR...
, and applicable regulatory requirements (FDA, EMA, etc.) Advanced problem-solving and root cause analysis skills Excellent project...
: Apply biostatistical methods to support clinical development, regulatory submissions (e.g., FDA, EMA), and evidence generation strategies...