- Abbott (Sylmar, CA)
- …regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating ... from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry experience preferred. Professional… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required.Medical device industry experience preferred. + Professional… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... liaison to ensure designs and products are meeting customer needs and regulatory requirements. + Understands the business units products and related clinical… more
- Stryker (Sacramento, CA)
- …desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements + ... The **Senior Director, Regulatory Affairs** is a key strategist, responsible for... Affairs** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and delivering… more
- Bayer (Berkeley, CA)
- …Audit & Observation management, Risk Management, etc.); + Expertise in cGMP and regulatory requirements ( FDA , EMA, ICH, etc.); + Expertise in performing ... in managing all aspects of investigations; * Maintain knowledge of current regulatory practices including a current understanding of USP/EP, cGMP regulations, ICH,… more
- BeOne Medicines (Emeryville, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more
- Abbott (Menlo Park, CA)
- …of work assignments. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, ... external customers (eg in supporting Marketing, Manufacturing Engineering, Production, Regulatory , and Quality Assurance, Physicians, and managing vendors). **What… more
- Abbott (San Diego, CA)
- …implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE: ... cross-functional partners such as Quality Assurance, Operations, Marketing and Regulatory Affairs. * Strong technical, negotiating, decision-making and analytical… more
- Abbott (Pleasanton, CA)
- …intellectual property. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + Experience… more
- Abbott (Milpitas, CA)
- …highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement **Preferred Qualifications** + Good ... the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and… more