- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- The Sourcing Project Manager position directs the activities related to the sourcing of assigned categories. Oversees and reviews the negotiations and content of ... and quality requirements. Encourage suppliers to be ISO certified and fulfill ISO and FDA requirements with suppliers as required and needed. + Must be willing to… more
- ThermoFisher Scientific (Austin, TX)
- …timeline. * Manages all clinical and administrative aspects of a clinical project , including site level study set-up, recruitment, conduction, and data collection. * ... and strong knowledge of clinical study operations * Knowledge of FDA regulations and ICH GCP guidelines * Knowledge of budgeting/forecasting/planning projects… more
- AbbVie (North Chicago, IL)
- …Responsibilities + Maintains the primary quality lead with management oversight for project Quality activities and the team members (within and outside of AbbVie) ... support, regulatory, and/or validation background is required. + Experience with FDA and other regulatory agency interactions and inspections is required. +… more
- Boehringer Ingelheim (St. Joseph, MO)
- …ensure the project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned ... **Description** Manager The Manager , Regulatory Affairs (RA)...and efficient communication through activities such as governance review, project team meetings, planning activities and FDA … more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Jarratt, VA)
- …person will provide expertise, strategic and technical guidance to the Plant Manager and the Site's Sanitation Managers. Working in conjunction with supporting ... associated with Sanitation KPI's, Internal & External Inspections (USDA, FDA , GFSI) and Customers Requirements. It is responsible for...FM) via RCA, FMEA, to deliver sustainable CAPA. + Project review and commissioning OQ, PQ, DQ, IQ +… more
- Actalent (Lake Forest, CA)
- …FDA CFR, EU MDR). Skills Regulatory, new product development, quality, 510(k), Project management, engineering, MDR, EU MDR, US FDA , regulatory submission, ... We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities....Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified Bodies. -… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining approval of ... 510(k), IDE, and PMA submissions to the US Food and Drug Administration ( FDA ) for class II and class III products. This position entails management of submissions to… more
- University of Washington (Seattle, WA)
- …Neck (THN) Research Program has an outstanding opportunity for a full-time Program Manager .** The Program Manager oversees the management and operations of the ... advancing initiatives in support of the THN strategic plan. The Program Manager supervises and partners closely with teams responsible for fiscal management,… more
- Perdue Farms, Inc. (Perry, GA)
- …**That's Perdue.** **Summary** We are actively recruiting for an experienced Sanitation Manager for our Perry-Harvest facility. This position will directly report to ... / GFSI requirements, and Sanitation Key Performance Indicators. The Site Sanitation Manager is also the technical liaison between the plant, corporate sanitation,… more
- Dentsply Sirona (Milford, DE)
- …role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and ... including 510(k) submissions, and technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the company for FDA … more