- GE HealthCare (State College, PA)
- …Summary** We are seeking a highly motivated and experienced Manufacturing Engineering Manager to lead the Manufacturing Engineering team in our ultrasound probe ... validation protocols. + Ensure compliance with regulatory standards (eg, ISO 13485, FDA QSR) and internal quality systems. + Manage capital equipment selection,… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... lives that makes ZOLL the ideal place to build your career.Job SummaryThe Manager of Embedded Systems Development is responsible for leading a team of hardware… more
- Philips (Pittsburgh, PA)
- **Clinical Study Manager , Computed Tomography (EST Time zone)** The Clinical Study Manager will be responsible for the execution and regulatory compliance of ... studies with strict adherence to protocols, regulatory standards (ISO, GCP, FDA ), and Philips procedures, ensuring data accuracy, integrity, and effective handling… more
- Omnicell (Warrendale, PA)
- **Facilities Manager ** Pittsburgh Area - Warrendale & Cranberry Township, PA, United States **JOB DESCRIPTION** The facilities manager is responsible the daily ... The individual will maintain positive customer relations, and support OSHA, FDA , Green Initiatives, and ISO requirements. The individual will develop facility… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals… more
- ThermoFisher Scientific (Allentown, PA)
- …communities depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is highly preferred **Position Summary** The ... Regulatory Intelligence Manager will play a pivotal role in monitoring, analyzing,...changes, guidance documents, and policy trends across key markets ( FDA , EMA, PMDA, etc.) or stakeholders (EU Commission, ICH,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** Manager , Quality Assurance External Manufacturing is responsible for managing ... and the suppliers. + Ensure regulatory and contractual compliance in accordance to FDA , ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations. + Develops… more
- Edwards Lifesciences (Pittsburgh, PA)
- …journey. The primary objective of **the Outreach and Physician Education Program Manager ** is to execute Transcatheter Heart Valve's (THV's) vision to ensure the ... that are in need and meet the requirements for treatment. The **OPE Manager ** will support the Provider Engagement and Strategic Sales Programs Team, with an… more
- Pfizer (Collegeville, PA)
- …the Clinical Development &Operations (CD&O) organization, the Senior Associate, eCOA Manager , Clinical Data Collection Strategies is responsible for assisting in the ... + Experience in eCOA study design + Demonstrated experience of project , vendor management + Practical experience interfacing and achieving concordance with… more
- Edwards Lifesciences (Harrisburg, PA)
- …lives. Join us and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing projects and team operations in compliance with ... Edwards criteria + Certification in related fields + Strong leadership in project and team management, including coaching and performance oversight. + Expertise in… more