- Fujifilm (Harrisburg, PA)
- **Position Overview** The Senior Project Manager , SDS manages, leads, and coordinates all aspects of the Synapse MI implementation process from quotation to ... **Duties and Responsibilities:** + Creates, manages, disseminates, and updates project documents including implementation plans, scope documents, status documents,… more
- Fujifilm (Harrisburg, PA)
- **Position Overview** The Associate Project Manager will play a pivotal role in supporting the execution of healthcare informatics projects, ensuring their ... and organized individual capable of coordinating across teams, tracking project milestones, and ensuring compliance with HCUS standards. The successful… more
- Philips (New Kensington, PA)
- …through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and global standards; manage project execution in ... The Sr. Project Manageris responsible for executing critical, multi-domain innovation...8+ years of professional experience in product/solution development within FDA -regulated medical device or technology sectors. + Minimum of… 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
- Fujifilm (Harrisburg, PA)
- …The next career level for a Project Coordinator will be Associate Project Manager if requirements are met. **Company Overview** At FUJIFILM Healthcare ... **Position Overview** The Project Coordinator plays a crucial role in supporting...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- NTT DATA North America (Pittsburgh, PA)
- …with structure and accountability while working under the guidance of a Project Manager . **Key Responsibilities** **Business Analysis - Health Care Focus** ... is seeking a highly experienced Senior Business Analyst & Project Coordinator with 10+ years of experience in the...user stories) aligned to compliance standards like HIPAA, HITECH, FDA , or CMS guidelines. + Perform gap analysis and… 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
- 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 ... a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, IG/EHT (Enabling Healthcare Technologies encompasses complex… more
- dsm-firmenich (Exton, PA)
- ** Manager , Engineering** **Exton, PA** The Manager , Engineering will provide purpose, direction, and motivation while operating to accomplish the goals and ... and products/ processes. They will direct or participate on project teams within the PMP/ project management process....the preparation of applicable technical sections of regulatory documents ( FDA 510k, IDE, PMA, CE), grants, & patent filings.… 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 ... therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The job is in our King of Prussia,… more