or plastic surgery practice is highly preferred. Software: Proficiency with dermatology-specific EHR software (e.g., EMA/ModMed...
and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively...
manufacturing, and represents and defends the validation and CSA programs during FDA, EMA, and other regulatory inspections. When... with current FDA, EMA, and ICH guidance Ensure validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, PV) meets regulatory...
· Lead statistical contributions to global regulatory submissions and interactions with major Health Authorities (FDA, EMA...
(e.g., FDA, EMA, ISO 13485, ISO 14971) Medical device and/or combination product complaint handling experience...
. Proficiency in medical terminology and dermatology. Familiarity with EMR systems such as NextGen and EMA. 1-2 years of recent...
, regulatory requirements (FDA, EMA, EU Annex 1), and client Quality Agreements. Acting as the primary quality authority on the... constant inspection readiness in accordance with FDA, EMA, and international regulatory expectations. Ensure compliance...
that validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards. Manage mid-size validation projects...
study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections May support...
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...