- NTT DATA North America (Pittsburgh, PA)
- …forward-thinking organization, apply now. NTT DATA's Client is currently seeking an IT Project Manager (dSME Program/Product) to join their team in Pittsburgh, ... Pennsylvania (US-PA), United States (US).REMOTE! Job Description: Project Overview The IT Project Manager will oversee multiple initiatives within the dSME… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …lives that makes ZOLL the ideal place to build your career. The Staff Operations Project Manager serves as a strategic leader and the primary bridge between ... multiple facilities + Experience in waterfall, agile, or hybrid project management approaches + Knowledge of relevant FDA... project management approaches + Knowledge of relevant FDA regulations (21 CFR, ISO 13485) + Familiarity with… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Clinical Research Nurse Project Manager (Department of Radiation Oncology) Job Profile Title Clinical ... Nurse D Job Description Summary The Clinical Research Nurse Project Manager will support all aspects of...participate in audits conducted by study sponsors, CROs, the FDA , the University of Pennsylvania's CTSRMC, and other regulatory… more
- Eurofins US Network (Lancaster, PA)
- …substances and products. **Job Description** **Role Overview** The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing ... role ensures timely delivery of testing services, adherence to regulatory standards ( FDA , EMA, ICH), and effective communication with internal teams and external… more
- PCI Pharma Services (Philadelphia, PA)
- …across our global network to pioneer and shape the future of PCI. Technical Project Manager ( IT Infrastructure & Cybersecurity) We are seeking a results-driven ... IT Project Manager to lead and coordinate a...global regions. Ensure projects align with regulatory requirements (GxP, FDA , ISO 27001) and corporate cybersecurity standards. Oversee system… 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
- Dentsply Sirona (York, PA)
- …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
- Oracle (Harrisburg, PA)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- CSL Behring (King Of Prussia, PA)
- …accelerate innovation and create greater impact for patients. With a streamlined, project -led structure and a focus on collaboration, we're building a future-ready ... meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is...programming based on US Code of Federal Regulations and FDA implementing regulations and guidance. + Adhere to related… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and… more
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