- CSL Behring (King Of Prussia, PA)
- …or reject promotional programming based on US Code of Federal Regulations and FDA implementing regulations and guidance. + Adhere to related SOPs and work ... reject material based on company practice, CSL policy, US law, and FDA regulations. + Collaborate with Commercial Operations Marketing, Legal, and Medical personnel… more
- Edwards Lifesciences (Allentown, PA)
- …+ As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager , Medical Affairs) is responsible for ... evaluations for a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen… more
- Wolters Kluwer (Philadelphia, PA)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the...Principal SaMD TPM acts as a bridge between engineering, product , regulatory affairs, clinical, and quality assurance… more
- TreeHouse Foods, Inc. (Womelsdorf, PA)
- …quality systems and initiatives. + Serve as the plant's liaison for regulatory authorities, including USDA, FDA , and third-party auditors. **_Important ... Type:** Quality **Job Posting Title:** Food Safety and Quality Manager **About Us** **:** TreeHouse Foods (NYSE: THS) is...PA site, a manufacturer of confections. This role upholds product quality, food safety, and sanitation in compliance with… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …roles and responsibilities and relationship between Olympus and the suppliers. + Ensure regulatory and contractual compliance in accordance to FDA , ISO 13485, ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** Manager , Quality Assurance External Manufacturing is responsible for managing… more
- Fujifilm (Harrisburg, PA)
- **Position Overview** The CPQ Product Marketing Manager , Medical Informatics (MI), manages our go-to CPQ market strategy and workflows for the Synapse Enterprise ... into the North America and Global markets The CPQ Product Marketing Manager would ensure we are...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Penn Medicine (Philadelphia, PA)
- …all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW, ... each day. Are you living your life's work? Job Title: Senior Practice Manager Department: Ortho Musculoskeletal 7 FL Location: Penn Medicine University City- 3737… more
- Edwards Lifesciences (Harrisburg, PA)
- …including coaching and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- GE HealthCare (State College, PA)
- …work instructions, PFMEAs, control plans, and validation protocols. + Ensure compliance with regulatory standards (eg, ISO 13485, FDA QSR) and internal quality ... Summary** We are seeking a highly motivated and experienced Manufacturing Engineering Manager to lead the Manufacturing Engineering team in our ultrasound probe… more
- University of Pennsylvania (Philadelphia, PA)
- …CROs, the FDA , the University of Pennsylvania's CTSRMC, and other regulatory groups. + Coordinate the administration of the investigational product and ... and resources, and much more. Posted Job Title Clinical Research Nurse Project Manager (Department of Radiation Oncology) Job Profile Title Clinical Research Nurse D… more