- United Therapeutics (Morrisville, NC)
- …Document all laboratory activities in compliance with GLP, CLIA, CAP, EFI, and/or FDA regulatory requirements + Assist in writing, reviewing, and updating SOPs, ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- IQVIA (Durham, NC)
- …significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more
- Reynolds American (Winston Salem, NC)
- …studies (eg, actual use trials, pragmatic trials) for tobacco products intended for FDA regulatory submissions. + Act as the primary liaison between clinical ... the planning, execution, monitoring, and closing of clinical research to support regulatory submissions and real-world experiences of our products. In this position,… more
- Oracle (Raleigh, NC)
- …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
- Herbalife (Winston Salem, NC)
- …experience or similar job experience* 5+ years' experience in cGMP, FDA regulatory requirements* Experience supporting the development/tracking of project ... Anniversary celebrations, etc.). Will coordinate documentation processes to support internal regulatory requirements and assisting in the management and care of… more
- Mentor Technical Group (Monroe, NC)
- …biotech, or medical device industry). + Knowledge: + Familiarity with GMP, FDA , and regulatory requirements for packaging operations. + Understanding of ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Mentor Technical Group (Durham, NC)
- …principles, cleanroom classifications, and sterile technique. + Familiarity with GMP, FDA , and regulatory requirements for sterile manufacturing. + Knowledge ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- United Therapeutics (Research Triangle Park, NC)
- …all assigned programs from inception (Phase 1-3) to successful product approval by the FDA and other regulatory agencies. + Design and review clinical protocols, ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Parexel (Raleigh, NC)
- …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
- ManpowerGroup (Raleigh, NC)
- …in CAD software such as SolidWorks and understanding of ISO and FDA regulatory requirements. + Knowledge of manufacturing processes including injection ... molding, die casting, metal stamping, and machining. **What's in it for me?** + Opportunity to work on innovative medical device projects that impact patient care. + Collaborative and inclusive work environment fostering professional growth. + Flexible hybrid… more