- DRT Strategies, Inc. (Arlington, VA)
- …procurements in the federal consulting market. We are seeking an experienced Capture Manager to identify and lead the capture of strategic opportunities, enabling us ... in achieving our ambitious growth objectives. Job Summary: The Capture Manager will lead end-to-end capture activities for high-priority opportunities across DRT.… more
- Medtronic (Minneapolis, MN)
- …a dynamic and fast-paced environment. This position reports to the Senior Program Manager - FDA /Life Sciences, Enterprise Legal Regulatory. This will be an onsite ... **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise...review + Provide support to the Senior Legal Program Manager to drive advertising and promotion process updates, review… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your ... role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil… more
- Actalent (Vernon Hills, IL)
- …potency, purity, and identity data, managing method transfers, and ensuring compliance with FDA , USP, and ICH guidelines. The manager will provide technical ... Job Title: QC Manager Job Description The QC Manager ...SOPs, deviations, and CAPA processes. + Ensure cGMP compliance ( FDA , USP, ICH, ISO). + Oversee equipment validation/calibration, and… 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 ... the results associated with Sanitation KPI's, Internal & External Inspections (USDA, FDA , GFSI) and Customers Requirements. It is responsible for identifying food… 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 ... PMA submissions to the US Food and Drug Administration ( FDA ) for class II and class III products. This...products. This position entails management of submissions to the FDA , requiring working knowledge of products under review and… more
- Schwan's Company (Minneapolis, MN)
- …passionate about driving regulatory excellence across the supply chain? As our Sr Manager , FSQ Regulatory Compliance, you will play a critical role in ensuring that ... our manufacturing facilities, suppliers, and co-packers consistently meet and exceed USDA, FDA , FSMA, SFCR, and other global food safety standards. You will lead… more
- Dentsply Sirona (Waltham, MA)
- …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 ... technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the...EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and… more
- ThermoFisher Scientific (Wilmington, NC)
- …compliance across our global manufacturing network. **DESCRIPTION** : The Senior Manager , Process and Cleaning Validation is responsible for providing technical and ... monitoring-are scientifically sound, risk-based, and compliant with global regulatory requirements ( FDA , EMA, WHO, PIC/S, and ICH Q7-Q10). The incumbent will serve… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …promoting department personnel.Strict adherence to procedures and practices according to FDA regulations.Strong emphasis on documentation according to FDA ... Minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. Aseptic experience is required.Equivalency: + In lieu of… more