- Penn Medicine (Philadelphia, PA)
- … Regulatory : Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... Flexible and readily adopts new processes and engages in practice operation changes. Performs duties in accordance with Penn Medicine and entity values, policies, and procedures. Other duties as assigned to support the unit, department, entity, and health… more
- Sanofi Group (Swiftwater, PA)
- …in accordance with current good manufacturing practices (cGMP) for all relevant regulatory agencies (eg FDA ). Positions within production facilities may change ... Ability to lift between 1 to 50 pounds per health center + Regulatory audit understanding and awareness **About You** **Basic Qualifications:** **High school diploma… more
- Penn Medicine (Radnor, PA)
- … Regulatory : Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... Flexible and readily adopts new processes and engages in practice operation changes. Education or Equivalent Experience: + HS Diploma/GED (Required) + 2+ years of medical office experience, or 2 years of customer service experience (Required) + Advanced… more
- GE HealthCare (State College, PA)
- …+ Collaborate with design, quality, planning, purchasing and operations teams to ensure compliance with regulatory standards. + Leverage data to identify and ... medical device manufacturing or ultrasound technology. + Familiarity with regulatory standards such as ISO and FDA ....with regulatory standards such as ISO and FDA . + Project management experience in cross-site or international… more
- Envista Holdings Corporation (Quakertown, PA)
- …growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced ... framework. + Assures that deliverables meet all relevant quality, safety, regulatory , serviceability, and reliability requirements. + Reviews code proposals and… more
- Globus Medical, Inc. (Audubon, PA)
- …Surveillance Reports (PMSR)** and **Periodic Safety Update Reports (PSUR)** in compliance with global regulatory standards. + Drive **risk analyses** ... extensions** , working closely with the R&D, clinical, and regulatory teams. + Champion **Design for Manufacturing (DFM)** improvements...or complaint handling systems. + Understanding of ISO 13485, FDA 21 CFR Part 820, or EU MDR regulations.… more
- Fujifilm (Harrisburg, PA)
- …high level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Teleflex (Wayne, PA)
- …as required by facility requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian ... and support to clinical end-users, clinical sales specialists, sales team, Regulatory , Engineering, marketing, and other corporate departments on safe and effective… more
- West Pharmaceutical Services (Williamsport, PA)
- …Champion a culture of health and safety in accordance with the highest standards of regulatory compliance . + End to end ownership for the full business value ... operations; prefer SAP and MS Office applications. + Experience working with ISO9000, FDA and cGMP required. + Ability to read and interpret documents and drawings,… more
- Fujifilm (Harrisburg, PA)
- …to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more