and EU MDR. Leadership experience or ability to mentor team members. Prior CAPA experience is a PLUS The base pay...
in preparing and submitting regulatory documentation including filings to the FDA, EU MDR, and/or other global regulatory agencies...
with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality...
information under the California Privacy Rights Act (CPRA) and special category data under the UK and EU GDPR. Providing... does not “sell” or “share” personal information as defined by the CPRA. Outside of the United States, for example in the EU...
cosmetic and personal care raw materials meet U.S. and international regulations, including FDA, EU Cosmetics Regulation, REACH..., nutraceutical, pharmaceutical, or food manufacturing. Knowledge of EU Cosmetics Regulation, REACH, and international compliance...
device or other regulated industry (FDA, EU MDR, ISO, or similar regulatory frameworks). Experience in labeling operations...
, with particular experience navigating EU MDR requirements for legacy and cleared devices. You design and oversee retrospective...
to their direct reports and cross-functional product development teams on US and EU regulatory requirements This role works closely... regulatory submissions, including 510(k) submissions, and technical files for CE marking Manages communications with FDA and EU...
, ARISg) · Excellent computer skills (MS Office) · Advanced knowledge of US and EU pharmacovigilance regulations...
device or other regulated industry (FDA, EU MDR, ISO, or similar regulatory frameworks). Experience in labeling operations...