- 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
- 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
- United Therapeutics (Morrisville, NC)
- …essential services that streamline patient access to therapy. Compliantly adhering to FDA and other regulatory guidelines, the Patient Navigator takes ownership ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- Oracle (Raleigh, NC)
- …of Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and ... Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. -...maintaining compliance to FDA and other Global regulatory requirements. - Proficiency in the Java programming language.… more
- Actalent (Sanford, NC)
- …documentation control, and project lifecycle management is a plus. + Familiarity with GMP, FDA , or other regulatory standards is a plus. + Experience with MEP ... with engineering teams to ensure technical accuracy and compliance with regulatory standards. Essential Skills + Associates or Bachelor's degree in Mechanical,… more
- Adecco US, Inc. (Monroe, NC)
- …development and process changes. . Serve as SME during internal audits and regulatory inspections ( FDA , ISO, Notified Bodies). . Maintain current knowledge of ... of sterilization modalities and microbiological testing methods. . Familiarity with ISO, FDA , and EU regulatory standards. . Excellent documentation, analytical,… more
- Perdue Farms, Inc. (Charlotte, NC)
- …Experience developing and maintaining company records relating to process work flows, USDA, FDA and other regulatory organizations + Thorough understanding of ... and Food Quality for Prepared Foods Division directs the food quality and regulatory compliance procedures and processes for the company. This person will oversee… more
- Endo International (Raleigh, NC)
- …and finished products to ensure they meet specifications.** + **Ensure adherence to FDA , EMA, and other regulatory standards, including PIC/S GMP requirements.** ... for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Fujifilm (Raleigh, NC)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more