International Sales and Logistics Manager in managing company's EU operations and associated systems. Assist with the preparation...
compliance with ISO 13485, 21CFR820, EU MDR, and global regulations, and manages interactions with regulatory agencies. The... regulatory submission activities for US, EU, and international markets. Prepare and author Design Dossiers, Technical Files...
and understanding of regulatory requirements (FDA, EU, cGMP, etc.), building codes, construction materials, and industry best practices...
details, please see Samba's . For residents of the EU , Samba Inc. is the data controller....
(EU 2017/745) CE Mark compliant Quality Management System. Manages and conducts cGMP and employee trainings. Maintains... but not limited to product registrations and customer licensing for FDA, MDSAP and EU MDR (CE Marking), and other international...
and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor...
for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory... and leadership Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team...
Associate Medical Director leads and drives strategy for the overall global (US/EU/Japan/China) clinical development taking... products. POSITION ACCOUNTABILITIES: Clinical Development team participation and leadership Leads Global (US/EU/Japan...
qualified (AUS/NZ, UK, EU or US bar admission) At least 5-7 years practicing law with some experience in-house, preferably...
our US/EU agency ecosystem. You’ll manage a portfolio of current agency partners, while sourcing and activating new strategic...