- University of Pennsylvania (Philadelphia, PA)
- …Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. ... to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory... FDA reporting, as well as provide direct regulatory /compliance guidance. The Regulatory Affairs Specialist C… more
- Oracle (Harrisburg, PA)
- …all device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's ... standards such as IEC 62304, IEC 82304, and relevant FDA guidance. + Proven ability to apply regulatory... FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation, and development practices.… more
- CSL Behring (King Of Prussia, PA)
- …media, HCP/patient brochures, press releases) for consistency with local and international regulatory requirements (eg, FDA , EMA, PMDA). * ** Regulatory ... within the pharmaceutical, biotechnology, or healthcare industry. *In-depth knowledge of global regulatory requirements and guidances (eg, FDA OPDP, EMA, Health… 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 + ... design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This… 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. + ... design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This… 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 + ... design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This… more
- 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
- Parexel (Harrisburg, PA)
- …Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) * ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure… 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 + 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