- Boehringer Ingelheim (Los Angeles, CA)
- …specialist role responsible for pull-through of the account plan (developed by the Account Manager ) at the Health System's various sites of care and with the Health ... + Uses approved account management techniques to facilitate the decision-making process and engagement. + Supports the Health Systems' Triple Aim efforts… more
- Medtronic (Irvine, CA)
- …if required. + Takes a leadership role in responding to relevant questions from FDA , FDA Advisory Panels, and/or other regulatory agencies, and in negotiations ... and analysis issues. + Lead development of policies and procedures for process improvements and standardization for the department and the statistics group. +… more
- Terumo Neuro (Aliso Viejo, CA)
- …coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties: + As ... for collecting and reviewing site regulatory documents. + Manage device accountability process . + Conduct Site Initiation Visits and Closure Visits at clinical study… more
- Envista Holdings Corporation (Pomona, CA)
- … process and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards. + Documents data obtained during ... Sr. Quality Engineer will report directly to the Quality Engineering Manager . **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Actively participates in defining customer… more
- CSL Plasma (Stockton, CA)
- **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance ... the development and implementation of continuous improvement plans + Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during… more
- Medtronic (Irvine, CA)
- …to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online and offline coordination with authors, ... needs. + Act as SME for Neurovascular Ad Promo process , providing guidance to authors and reviewers on regulatory... documents + Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code… more
- Fujifilm (Sacramento, CA)
- …on systems within a service area as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to ... follow-up, leading to customer satisfaction. + Utilizing the escalation process to resolve customer service delivery issues and conducting...Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and… more
- Meta (Burlingame, CA)
- …Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or indirectly with international regulatory agencies on most ... reviewer level. All significant issues will be reviewed with the manager 2. Support regulatory compliance activities, including site registration, audits,… more
- Medtronic (Los Angeles, CA)
- …LIII engineering field support by following the appropriate use of the escalation process , when other avenues for resolution are exhausted. This activity may include ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Highmark Health (Sacramento, CA)
- …and testing processes in partnership with the pharmacy benefits manager . The successful candidate will possess excellent communication, analytical, and ... a fast-paced and collaborative environment. **ESSENTIAL RESPONSIBILITIES** + Monitor FDA -approvals, drug manufacturer pipelines, assess drug utilization reports, and… more