- Geisinger (Danville, PA)
- …+ Supports inspections/audits from regulatory/recommending bodies including TJC, PA DEP, FDA , ACR, and DOH. + Supports/oversees use of advanced medical imaging ... College of Radiology (ACR) and United States Food and Drug Administration ( FDA ) definition of a qualified medical physicist (QMP). Certification status will be… more
- System One (Pittsburgh, PA)
- …+ Ensure all statistical work complies with relevant regulatory guidelines (eg, FDA , EMA) and Good Clinical Practices (GCP). + Use statistical software such ... knowledge of clinical trial design, statistical methods, and regulatory requirements ( FDA , EMA). + Experience with developing statistical analysis plans (SAPs) and… more
- Globus Medical, Inc. (Audubon, PA)
- …and implants using CAD software (CREO). + Create and maintain project plans and FDA -compliant Design History Files (DHF) for each project. + Manages all aspects of ... prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other regulatory bodies. + **Customer Engagement:** + Obtain market feedback… more
- Kedplasma (Pittston, PA)
- …Director. Operates within the scope of EU Guidance on Good Manufacturing Practices and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... that meet the criteria of normal plasma donors in accordance with SOPs, the FDA , OSHA, CLIA and cGMP and company policies as well as educational experience. +… more
- Kedplasma (Pittston, PA)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and care of the donor… more
- Highmark Health (Pittsburgh, PA)
- …a fast-paced and collaborative environment. **ESSENTIAL RESPONSIBILITIES** + Monitor FDA -approvals, drug manufacturer pipelines, assess drug utilization reports, and ... Assist in the development of Gateway's Drug Formularies by monitoring FDA -approvals and drug manufacturer pipelines, assessing drug utilization reports, and writing… more
- dsm-firmenich (Exton, PA)
- …development. + Manage the preparation of applicable technical sections of regulatory documents ( FDA 510k, IDE, PMA, CE), grants, & patent filings. + Execute the job ... within the applicable DSM, OSHA, EPA, ISO, FDA , CE, & other requirements. **We Bring:** + A competitive compensation package, with comprehensive health and welfare… more
- Community Health Systems (Dunmore, PA)
- …of breast diseases. This role requires advanced technical skills, adherence to FDA /MQSA, ACR, and state regulatory standards, and a strong commitment to patient ... positioning, imaging techniques, and radiation protection. + Strong understanding of FDA /MQSA, ACR, and state regulatory compliance requirements. + Ability to… more
- Canon USA & Affiliates (Harrisburg, PA)
- …of reportable events + Provide information as requested for the filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and ... requirements/actions + Assist in maintaining proper preparedness for State or Federal ( FDA ) authorities + Represent interests of RA in cross functional teams as… more
- Globus Medical, Inc. (Audubon, PA)
- …design specifications for new product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project + Manage of all ... and market plans + Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + Collaborate with the operations department to setup… more