- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assists in the writing of regulatory applications to the FDA and other regulatory bodies + Partners ... design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + ... specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all… more
- Globus Medical, Inc. (Audubon, PA)
- …shops and external vendors for rapid prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other regulatory bodies. + ... 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… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + ... product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...full compliance with Globus quality system and other applicable regulatory bodies + Design and develop instruments and implants… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... (CROs) (ie, source documentation, case report forms, study and regulatory binders, and patient binders). + Resolve data queries...the conduct of audits by study sponsors, CROs, the FDA , and other entities as required. + Process and… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + ... specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all… more
- Sumitomo Pharma (Harrisburg, PA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA… more
- Honeywell (Pottsville, PA)
- …new drug product registration process including ICH stability guidelines. Familiarity with FDA , EMEA & Japanese Regulatory requirements relating to package ... and resources, ensuring that R&D projects adhere to industry standards, regulatory requirements, and Advanced Materials' quality and safety protocols. **KEY… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- PCI Pharma Services (Philadelphia, PA)
- …in a regulated environment + Demonstrated expertise in quality management systems and regulatory requirements ( FDA , ISO 13485, Medical Device Directive) + Strong ... the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role leads the implementation,… more