- Globus Medical, Inc. (Audubon, PA)
- …guides, brochures and other marketing/sales support materials + Partnering with Regulatory Affairs in planning, coordination, writing, and execution of 510(k), IDE ... & PMA submissions and approvals + Collaborating with VP, Strategy & Corporate Development to ensure that Globus can attract and retain the best orthopedic/trauma… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …better understanding. + Processes reportability decisions and is able to complete MDR submissions . + Assist in the preparation of regulatory body additional ... The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more
- University of Pennsylvania (Philadelphia, PA)
- …when regulatory questions arise and respond to communications generated from regulatory submissions . Ensure that regulatory submissions meet ... This position requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient safety and data… more
- University of Pennsylvania (Philadelphia, PA)
- …related activities delegated to research coordinator who provides study related support (eg, regulatory submissions and data entry). + May be responsible for ... activities delegated to research coordinators/assistants who provide study related support (eg, regulatory submissions and data entry). May be responsible for… more
- University of Pennsylvania (Philadelphia, PA)
- …complex Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, ... Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research...IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute… more
- University of Pennsylvania (Philadelphia, PA)
- …studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed. ... subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating… more
- Geisinger (Danville, PA)
- …for assisting with coordination of research projects including protocol implementation, regulatory submissions , project planning, project tracking, and data ... the project manager . + Ensures adherence to federal or other regulatory requirements. + Assists in the development, implementation and coordination of protocols.… more
- Guthrie (Sayre, PA)
- …coding and initiate corrected claims and appeals. Interprets payer guidelines, regulatory guidelines, contractual obligations and works with Department Management to ... Subject Matter Expert (SME). Works directly with Billing staff, Billing Supervisor/ Manager /Director, Application Analyst and CRC departments when needed, to resolve… more
- Carrington (Coraopolis, PA)
- …and other assessment documentation to ensure compliance with audit controls and regulatory requirements. + Create and maintain a repository of support documentation ... for audit/assessment submissions to ensure consistency across all requests. + Actively...+ Ensure the continuity and accuracy of audit and regulatory responses. + Review the IT Department policies and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to internal and external stakeholders; support Publication strategies. + Support Regulatory submissions . + Facilitate communication between Sales and Marketing, ... closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus'… more
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