- Globus Medical, Inc. (San Diego, CA)
- …product managers to develop forecasts and market plans + Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + ... product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...full compliance with Globus quality system and other applicable regulatory bodies + Design and develop instruments and implants… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... blueprint reading and experience with inspection sampling techniques. Knowledge of FDA , GMP, ISO 13485. Good communication and computer skills, including Microsoft… more
- Abbott (Sylmar, CA)
- …regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating ... ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes, policies and rules is… more
- Abbott (Pleasanton, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Institute efficient communication and cross-functional collaborations with marketing, quality, regulatory , clinical, project management, etc, at multiple levels. +… more
- Hologic (San Diego, CA)
- …document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements ( FDA , ISO, EU MDR). + Conduct initial assessments ... + Regulatory Reporting + Support preparation and submission of regulatory reports (eg, FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory … more
- Sumitomo Pharma (Sacramento, CA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA… more
- Abbott (Pleasanton, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... closely with cross-functional peers in quality, operation, marketing, clinical and regulatory , medical affairs, commercials to define an aligned and predictable NPD… more
- Fujifilm (Sacramento, CA)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Abbott (Pomona, CA)
- …development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. + Responsible for exhibiting ... validated rooms and equipment. **WHAT YOU'LL DO** + Applies basic understanding of FDA , ISO and cGMP theories and principles. + Contribute to Group's objectives by… more
- Abbott (Pleasanton, CA)
- …and Control Plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, ... experience and demonstrated use of Quality tools/methodologies + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 + Solid communication and interpersonal… more